Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (NCT NCT03622593)
NCT ID: NCT03622593
Last Updated: 2025-07-11
Results Overview
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.
COMPLETED
PHASE3
951 participants
From Baseline through Week 56
2025-07-11
Participant Flow
Participant milestones
| Measure |
A: Faricimab 6 mg Q8W
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Overall Study
STARTED
|
317
|
319
|
315
|
|
Overall Study
Received at Least One Dose of Study Drug
|
317
|
319
|
314
|
|
Overall Study
Completed up to Week 56
|
298
|
312
|
299
|
|
Overall Study
COMPLETED
|
275
|
288
|
267
|
|
Overall Study
NOT COMPLETED
|
42
|
31
|
48
|
Reasons for withdrawal
| Measure |
A: Faricimab 6 mg Q8W
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
9
|
13
|
|
Overall Study
Death
|
12
|
9
|
10
|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
8
|
|
Overall Study
Adverse Event
|
4
|
5
|
6
|
|
Overall Study
Physician Decision
|
2
|
1
|
6
|
|
Overall Study
Other
|
2
|
2
|
3
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
1
|
Baseline Characteristics
The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
Baseline characteristics by cohort
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
Total
n=951 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
ITT Population
|
62.5 Years
STANDARD_DEVIATION 10.1 • n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
61.6 Years
STANDARD_DEVIATION 10.1 • n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
62.3 Years
STANDARD_DEVIATION 10.1 • n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
62.2 Years
STANDARD_DEVIATION 10.1 • n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Age, Continuous
Treatment-Naive Population
|
62.5 Years
STANDARD_DEVIATION 9.9 • n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
61.3 Years
STANDARD_DEVIATION 10.3 • n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
62.5 Years
STANDARD_DEVIATION 10.0 • n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
62.1 Years
STANDARD_DEVIATION 10.0 • n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Sex: Female, Male
ITT Population · Female
|
123 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
120 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
129 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
372 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Sex: Female, Male
ITT Population · Male
|
194 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
199 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
186 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
579 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Sex: Female, Male
Treatment-Naive Population · Female
|
100 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
94 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
97 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
291 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Sex: Female, Male
Treatment-Naive Population · Male
|
154 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
161 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
151 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
466 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
ITT Population · Hispanic or Latino
|
56 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
78 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
67 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
201 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
ITT Population · Not Hispanic or Latino
|
252 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
232 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
240 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
724 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
ITT Population · Unknown or Not Reported
|
9 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
9 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
26 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
Treatment-Naive Population · Hispanic or Latino
|
42 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
57 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
54 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
153 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
Treatment-Naive Population · Not Hispanic or Latino
|
204 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
190 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
188 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
582 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Ethnicity (NIH/OMB)
Treatment-Naive Population · Unknown or Not Reported
|
8 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
22 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · American Indian or Alaska Native
|
0 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · Asian
|
34 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
36 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
32 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
102 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
2 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · Black or African American
|
18 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
23 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
24 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
65 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · White
|
250 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
249 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
253 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
752 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · More than one race
|
2 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
ITT Population · Unknown or Not Reported
|
11 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
10 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
26 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · American Indian or Alaska Native
|
0 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · Asian
|
26 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
29 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
25 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
80 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
2 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · Black or African American
|
16 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
20 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
17 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
53 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · White
|
197 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
197 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
201 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
595 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · More than one race
|
2 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Race (NIH/OMB)
Treatment-Naive Population · Unknown or Not Reported
|
11 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
24 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Previous Treatment Status with Intravitreal Anti-VEGF Agents
Treatment-Naive
|
254 Participants
n=317 Participants
|
255 Participants
n=319 Participants
|
248 Participants
n=315 Participants
|
757 Participants
n=951 Participants
|
|
Number of Participants by Previous Treatment Status with Intravitreal Anti-VEGF Agents
Previously Treated
|
63 Participants
n=317 Participants
|
64 Participants
n=319 Participants
|
67 Participants
n=315 Participants
|
194 Participants
n=951 Participants
|
|
Region of Enrollment
ITT Population · United States and Canada
|
110 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
111 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
109 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
330 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Region of Enrollment
ITT Population · Asia
|
29 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
29 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
26 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
84 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Region of Enrollment
ITT Population · Rest of the World
|
178 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
179 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
180 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
537 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Region of Enrollment
Treatment-Naive Population · United States and Canada
|
87 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
88 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
84 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
259 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Region of Enrollment
Treatment-Naive Population · Asia
|
23 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
24 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
21 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
68 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Region of Enrollment
Treatment-Naive Population · Rest of the World
|
144 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
143 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
143 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
430 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Eye Chosen as the Study Eye (Left or Right)
ITT Population · Left Eye
|
156 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
168 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
146 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
470 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Eye Chosen as the Study Eye (Left or Right)
ITT Population · Right Eye
|
161 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
151 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
169 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
481 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Eye Chosen as the Study Eye (Left or Right)
Treatment-Naive Population · Left Eye
|
128 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
136 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
117 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
381 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Eye Chosen as the Study Eye (Left or Right)
Treatment-Naive Population · Right Eye
|
126 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
119 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
131 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
376 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Baseline Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
ITT Population
|
61.9 ETDRS Letters
STANDARD_DEVIATION 10.1 • n=316 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.5 ETDRS Letters
STANDARD_DEVIATION 9.3 • n=317 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.1 ETDRS Letters
STANDARD_DEVIATION 9.4 • n=315 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.1 ETDRS Letters
STANDARD_DEVIATION 9.6 • n=948 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
|
Baseline Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
Treatment-Naive Population
|
62.1 ETDRS Letters
STANDARD_DEVIATION 10.1 • n=253 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.8 ETDRS Letters
STANDARD_DEVIATION 9.3 • n=253 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.6 ETDRS Letters
STANDARD_DEVIATION 9.2 • n=248 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
62.5 ETDRS Letters
STANDARD_DEVIATION 9.5 • n=754 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. 3 participants (1 in Arm A and 2 in Arm B) were excluded for missing or invalid BCVA values.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
ITT Population · ≤38 Letters
|
14 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
11 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
9 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
34 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
ITT Population · 39 to 63 Letters
|
128 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
132 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
132 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
392 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
ITT Population · ≥64 Letters
|
174 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
174 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
174 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
522 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
ITT Population · Missing/Invalid BCVA
|
1 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
2 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
Treatment-Naive Population · ≤38 Letters
|
10 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
23 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
Treatment-Naive Population · 39 to 63 Letters
|
100 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
103 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
100 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
303 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
Treatment-Naive Population · ≥64 Letters
|
143 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
142 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
143 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
428 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by the Baseline BCVA Letter Score Categories in the Study Eye
Treatment-Naive Population · Missing/Invalid BCVA
|
1 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
2 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 1 - Diabetic Retinopathy (DR) Absent
|
2 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
4 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
7 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 2 - DR Questionable / Microaneurysms Only
|
3 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
10 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
19 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 3 - Mild Non-Proliferative Diabetic Retinopathy (NPDR)
|
90 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
92 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
94 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
276 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 4 - Moderate NPDR
|
88 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
72 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
79 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
239 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 5 - Moderately Severe NPDR
|
59 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
63 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
54 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
176 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 6 - Severe NPDR
|
50 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
36 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
51 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
137 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 7 - Mild Proliferative Diabetic Retinopathy (PDR)
|
12 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
26 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
11 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
49 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 8 - Moderate PDR
|
6 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
10 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
22 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 9 - High Risk PDR (DRS Level 71)
|
2 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 10 - High Risk PDR (DRS Level 75)
|
0 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 11 - Advanced PDR (DRS Level 81)
|
0 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · 12 - Advanced PDR (DRS Level 85)
|
0 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · Cannot Grade
|
2 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
12 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
ITT Population · Missing
|
3 Participants
n=317 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=319 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=315 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=951 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 1 - Diabetic Retinopathy (DR) Absent
|
2 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 2 - DR Questionable / Microaneurysms Only
|
1 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
15 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 3 - Mild Non-Proliferative Diabetic Retinopathy (NPDR)
|
63 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
66 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
71 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
200 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 4 - Moderate NPDR
|
74 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
59 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
56 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
189 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 5 - Moderately Severe NPDR
|
48 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
56 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
43 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
147 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 6 - Severe NPDR
|
44 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
32 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
47 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
123 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 7 - Mild Proliferative Diabetic Retinopathy (PDR)
|
11 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
17 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
7 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
35 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 8 - Moderate PDR
|
5 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
9 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
19 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 9 - High Risk PDR (DRS Level 71)
|
2 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
1 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
3 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
6 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 10 - High Risk PDR (DRS Level 75)
|
0 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 11 - Advanced PDR (DRS Level 81)
|
0 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · 12 - Advanced PDR (DRS Level 85)
|
0 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · Cannot Grade
|
1 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
4 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
4 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
9 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Number of Participants by Baseline Diabetic Retinopathy Severity (DRS) Status in the Study Eye
Treatment-Naive Population · Missing
|
3 Participants
n=254 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
0 Participants
n=255 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
5 Participants
n=248 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
8 Participants
n=757 Participants • The ITT and Treatment-Naive (TN) Populations are grouped according to treatment assigned at randomization. The ITT Population (951) includes all global participants randomized in the study. The TN Population (757), a subset of ITT, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization.
|
|
Baseline Central Subfield Thickness in the Study Eye
ITT Population
|
466.2 microns
STANDARD_DEVIATION 119.4 • n=314 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
471.3 microns
STANDARD_DEVIATION 127.0 • n=316 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
477.3 microns
STANDARD_DEVIATION 129.4 • n=312 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
471.6 microns
STANDARD_DEVIATION 125.3 • n=942 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
|
Baseline Central Subfield Thickness in the Study Eye
Treatment-Naive Population
|
464.6 microns
STANDARD_DEVIATION 117.9 • n=251 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
473.0 microns
STANDARD_DEVIATION 130.5 • n=252 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
474.3 microns
STANDARD_DEVIATION 129.5 • n=248 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
470.6 microns
STANDARD_DEVIATION 126.0 • n=751 Participants • The ITT Population (951) includes all global participants randomized in the study. The Treatment-Naive Population (757), ITT subset, includes randomized participants who had not received any IVT anti-VEGF agents in the study eye before randomization. Nine participants in the ITT (3 per arm) were excluded for missing or ungradable assessments.
|
PRIMARY outcome
Timeframe: From Baseline through Week 56Population: ITT Population and Treatment-Naive Population
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
11.8 ETDRS Letters
Interval 10.6 to 13.0
|
10.8 ETDRS Letters
Interval 9.6 to 11.9
|
10.3 ETDRS Letters
Interval 9.1 to 11.4
|
|
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
11.7 ETDRS Letters
Interval 10.4 to 13.0
|
11.2 ETDRS Letters
Interval 9.9 to 12.4
|
10.5 ETDRS Letters
Interval 9.2 to 11.9
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 97.5% confidence interval (CI) is a rounding of 97.52% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=231 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=251 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=238 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations
ITT Population
|
44.2 Percentage of participants
Interval 37.1 to 51.4
|
43.7 Percentage of participants
Interval 36.8 to 50.7
|
46.8 Percentage of participants
Interval 39.8 to 53.8
|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
46.9 Percentage of participants
Interval 38.7 to 55.1
|
45.7 Percentage of participants
Interval 37.8 to 53.7
|
52.3 Percentage of participants
Interval 44.2 to 60.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 95% CI is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 16
|
9.9 ETDRS Letters
Interval 9.0 to 10.7
|
9.8 ETDRS Letters
Interval 9.0 to 10.7
|
8.8 ETDRS Letters
Interval 7.9 to 9.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 20
|
10.1 ETDRS Letters
Interval 9.2 to 10.9
|
9.5 ETDRS Letters
Interval 8.6 to 10.4
|
8.8 ETDRS Letters
Interval 8.0 to 9.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 24
|
10.6 ETDRS Letters
Interval 9.7 to 11.5
|
9.9 ETDRS Letters
Interval 9.0 to 10.8
|
9.3 ETDRS Letters
Interval 8.4 to 10.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 28
|
10.7 ETDRS Letters
Interval 9.7 to 11.6
|
10.5 ETDRS Letters
Interval 9.6 to 11.4
|
9.6 ETDRS Letters
Interval 8.7 to 10.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 4
|
6.1 ETDRS Letters
Interval 5.4 to 6.8
|
6.6 ETDRS Letters
Interval 5.8 to 7.3
|
6.4 ETDRS Letters
Interval 5.7 to 7.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 8
|
7.8 ETDRS Letters
Interval 7.0 to 8.5
|
8.1 ETDRS Letters
Interval 7.4 to 8.9
|
7.5 ETDRS Letters
Interval 6.8 to 8.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 12
|
8.7 ETDRS Letters
Interval 7.8 to 9.5
|
9.1 ETDRS Letters
Interval 8.2 to 9.9
|
8.5 ETDRS Letters
Interval 7.7 to 9.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 32
|
11.3 ETDRS Letters
Interval 10.3 to 12.3
|
10.2 ETDRS Letters
Interval 9.2 to 11.1
|
9.4 ETDRS Letters
Interval 8.5 to 10.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 36
|
11.0 ETDRS Letters
Interval 10.1 to 12.0
|
10.6 ETDRS Letters
Interval 9.6 to 11.6
|
10.4 ETDRS Letters
Interval 9.5 to 11.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 40
|
11.4 ETDRS Letters
Interval 10.3 to 12.5
|
10.7 ETDRS Letters
Interval 9.6 to 11.7
|
10.3 ETDRS Letters
Interval 9.2 to 11.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 44
|
11.7 ETDRS Letters
Interval 10.7 to 12.7
|
10.9 ETDRS Letters
Interval 9.9 to 11.9
|
10.5 ETDRS Letters
Interval 9.5 to 11.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 48
|
11.8 ETDRS Letters
Interval 10.7 to 12.9
|
10.6 ETDRS Letters
Interval 9.5 to 11.7
|
10.1 ETDRS Letters
Interval 9.0 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 52
|
11.6 ETDRS Letters
Interval 10.5 to 12.6
|
10.7 ETDRS Letters
Interval 9.6 to 11.7
|
10.4 ETDRS Letters
Interval 9.3 to 11.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 56
|
11.6 ETDRS Letters
Interval 10.4 to 12.8
|
10.6 ETDRS Letters
Interval 9.5 to 11.8
|
9.9 ETDRS Letters
Interval 8.7 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 60
|
11.4 ETDRS Letters
Interval 10.2 to 12.6
|
10.1 ETDRS Letters
Interval 8.9 to 11.3
|
10.1 ETDRS Letters
Interval 8.9 to 11.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 64
|
11.6 ETDRS Letters
Interval 10.4 to 12.7
|
10.3 ETDRS Letters
Interval 9.2 to 11.5
|
9.4 ETDRS Letters
Interval 8.2 to 10.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 68
|
11.2 ETDRS Letters
Interval 10.0 to 12.3
|
10.1 ETDRS Letters
Interval 9.0 to 11.3
|
10.0 ETDRS Letters
Interval 8.8 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 72
|
11.2 ETDRS Letters
Interval 9.9 to 12.4
|
9.9 ETDRS Letters
Interval 8.8 to 11.1
|
9.4 ETDRS Letters
Interval 8.2 to 10.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 76
|
10.6 ETDRS Letters
Interval 9.3 to 11.9
|
9.4 ETDRS Letters
Interval 8.1 to 10.7
|
9.5 ETDRS Letters
Interval 8.2 to 10.8
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 80
|
10.6 ETDRS Letters
Interval 9.2 to 12.0
|
9.5 ETDRS Letters
Interval 8.1 to 10.9
|
9.1 ETDRS Letters
Interval 7.7 to 10.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 84
|
9.8 ETDRS Letters
Interval 8.4 to 11.2
|
10.3 ETDRS Letters
Interval 9.0 to 11.7
|
9.6 ETDRS Letters
Interval 8.2 to 11.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 88
|
9.8 ETDRS Letters
Interval 8.4 to 11.3
|
10.0 ETDRS Letters
Interval 8.6 to 11.4
|
9.2 ETDRS Letters
Interval 7.7 to 10.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 92
|
10.8 ETDRS Letters
Interval 9.3 to 12.2
|
10.2 ETDRS Letters
Interval 8.8 to 11.7
|
9.3 ETDRS Letters
Interval 7.9 to 10.8
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 96
|
11.3 ETDRS Letters
Interval 9.8 to 12.8
|
10.5 ETDRS Letters
Interval 9.1 to 12.0
|
9.0 ETDRS Letters
Interval 7.5 to 10.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Week 100
|
10.7 ETDRS Letters
Interval 9.1 to 12.3
|
9.5 ETDRS Letters
Interval 7.9 to 11.0
|
9.8 ETDRS Letters
Interval 8.2 to 11.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best-Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
11.7 ETDRS Letters
Interval 10.5 to 12.8
|
11.1 ETDRS Letters
Interval 9.9 to 12.2
|
10.7 ETDRS Letters
Interval 9.5 to 11.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
6.0 ETDRS Letters
Interval 5.2 to 6.9
|
6.7 ETDRS Letters
Interval 5.8 to 7.5
|
6.3 ETDRS Letters
Interval 5.4 to 7.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
7.5 ETDRS Letters
Interval 6.6 to 8.4
|
8.2 ETDRS Letters
Interval 7.3 to 9.1
|
7.3 ETDRS Letters
Interval 6.4 to 8.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
8.7 ETDRS Letters
Interval 7.8 to 9.6
|
9.2 ETDRS Letters
Interval 8.3 to 10.1
|
8.5 ETDRS Letters
Interval 7.6 to 9.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
9.7 ETDRS Letters
Interval 8.8 to 10.7
|
10.0 ETDRS Letters
Interval 9.1 to 10.9
|
8.7 ETDRS Letters
Interval 7.8 to 9.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
10.0 ETDRS Letters
Interval 9.1 to 11.0
|
9.8 ETDRS Letters
Interval 8.8 to 10.7
|
9.0 ETDRS Letters
Interval 8.1 to 10.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
10.6 ETDRS Letters
Interval 9.6 to 11.6
|
10.2 ETDRS Letters
Interval 9.2 to 11.2
|
9.4 ETDRS Letters
Interval 8.4 to 10.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
10.8 ETDRS Letters
Interval 9.8 to 11.8
|
10.8 ETDRS Letters
Interval 9.8 to 11.8
|
9.9 ETDRS Letters
Interval 8.9 to 10.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
11.2 ETDRS Letters
Interval 10.1 to 12.3
|
10.3 ETDRS Letters
Interval 9.2 to 11.4
|
9.9 ETDRS Letters
Interval 8.8 to 11.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
10.8 ETDRS Letters
Interval 9.7 to 11.9
|
10.9 ETDRS Letters
Interval 9.8 to 12.0
|
10.5 ETDRS Letters
Interval 9.3 to 11.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
11.3 ETDRS Letters
Interval 10.2 to 12.5
|
11.2 ETDRS Letters
Interval 10.0 to 12.3
|
10.6 ETDRS Letters
Interval 9.5 to 11.8
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
11.5 ETDRS Letters
Interval 10.4 to 12.7
|
11.2 ETDRS Letters
Interval 10.1 to 12.3
|
11.1 ETDRS Letters
Interval 9.9 to 12.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
11.4 ETDRS Letters
Interval 10.2 to 12.7
|
10.9 ETDRS Letters
Interval 9.7 to 12.1
|
10.5 ETDRS Letters
Interval 9.3 to 11.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
11.4 ETDRS Letters
Interval 10.0 to 12.8
|
11.0 ETDRS Letters
Interval 9.6 to 12.3
|
10.0 ETDRS Letters
Interval 8.6 to 11.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
11.4 ETDRS Letters
Interval 10.0 to 12.7
|
10.5 ETDRS Letters
Interval 9.2 to 11.8
|
10.1 ETDRS Letters
Interval 8.8 to 11.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
11.6 ETDRS Letters
Interval 10.2 to 12.9
|
10.5 ETDRS Letters
Interval 9.2 to 11.8
|
9.5 ETDRS Letters
Interval 8.2 to 10.8
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
11.2 ETDRS Letters
Interval 9.9 to 12.5
|
10.3 ETDRS Letters
Interval 9.0 to 11.6
|
10.0 ETDRS Letters
Interval 8.7 to 11.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
11.1 ETDRS Letters
Interval 9.7 to 12.5
|
10.1 ETDRS Letters
Interval 8.8 to 11.5
|
9.6 ETDRS Letters
Interval 8.2 to 10.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
10.6 ETDRS Letters
Interval 9.0 to 12.1
|
9.7 ETDRS Letters
Interval 8.2 to 11.2
|
9.5 ETDRS Letters
Interval 8.0 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
10.9 ETDRS Letters
Interval 9.4 to 12.5
|
10.0 ETDRS Letters
Interval 8.5 to 11.5
|
9.3 ETDRS Letters
Interval 7.8 to 10.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
9.9 ETDRS Letters
Interval 8.4 to 11.5
|
10.8 ETDRS Letters
Interval 9.3 to 12.3
|
9.6 ETDRS Letters
Interval 8.0 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
9.6 ETDRS Letters
Interval 7.9 to 11.2
|
10.2 ETDRS Letters
Interval 8.6 to 11.8
|
9.4 ETDRS Letters
Interval 7.8 to 11.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
10.4 ETDRS Letters
Interval 8.8 to 12.1
|
10.6 ETDRS Letters
Interval 9.0 to 12.2
|
9.6 ETDRS Letters
Interval 7.9 to 11.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
10.6 ETDRS Letters
Interval 8.9 to 12.3
|
10.9 ETDRS Letters
Interval 9.2 to 12.5
|
9.0 ETDRS Letters
Interval 7.3 to 10.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
10.4 ETDRS Letters
Interval 8.5 to 12.2
|
10.0 ETDRS Letters
Interval 8.2 to 11.7
|
9.8 ETDRS Letters
Interval 7.9 to 11.6
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=293 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Gaining ≥15 Letters
|
33.8 Percentage of participants
Interval 28.4 to 39.2
|
28.5 Percentage of participants
Interval 23.6 to 33.3
|
30.3 Percentage of participants
Interval 25.0 to 35.5
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Gaining ≥10 Letters
|
59.3 Percentage of participants
Interval 53.6 to 64.9
|
53.0 Percentage of participants
Interval 47.5 to 58.5
|
53.9 Percentage of participants
Interval 48.3 to 59.5
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Gaining ≥5 Letters
|
81.8 Percentage of participants
Interval 77.3 to 86.4
|
77.4 Percentage of participants
Interval 72.7 to 82.1
|
78.0 Percentage of participants
Interval 73.3 to 82.7
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Gaining ≥0 Letters
|
92.1 Percentage of participants
Interval 89.0 to 95.3
|
91.1 Percentage of participants
Interval 87.8 to 94.3
|
91.4 Percentage of participants
Interval 88.2 to 94.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
13.4 Percentage of participants
Interval 9.9 to 17.0
|
10.8 Percentage of participants
Interval 7.5 to 14.2
|
10.6 Percentage of participants
Interval 7.3 to 14.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
15.2 Percentage of participants
Interval 11.2 to 19.1
|
16.7 Percentage of participants
Interval 12.7 to 20.8
|
15.4 Percentage of participants
Interval 11.5 to 19.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
20.7 Percentage of participants
Interval 16.3 to 25.1
|
22.1 Percentage of participants
Interval 17.6 to 26.5
|
19.3 Percentage of participants
Interval 15.0 to 23.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
24.4 Percentage of participants
Interval 19.7 to 29.1
|
24.3 Percentage of participants
Interval 19.7 to 28.8
|
23.1 Percentage of participants
Interval 18.5 to 27.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
26.7 Percentage of participants
Interval 21.8 to 31.6
|
21.3 Percentage of participants
Interval 16.8 to 25.7
|
22.8 Percentage of participants
Interval 18.3 to 27.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
29.8 Percentage of participants
Interval 24.7 to 34.9
|
24.0 Percentage of participants
Interval 19.3 to 28.6
|
24.6 Percentage of participants
Interval 19.8 to 29.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
30.1 Percentage of participants
Interval 25.0 to 35.3
|
26.7 Percentage of participants
Interval 21.9 to 31.5
|
25.7 Percentage of participants
Interval 20.7 to 30.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
35.9 Percentage of participants
Interval 30.6 to 41.3
|
27.3 Percentage of participants
Interval 22.2 to 32.3
|
23.9 Percentage of participants
Interval 19.1 to 28.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
33.8 Percentage of participants
Interval 28.5 to 39.1
|
32.1 Percentage of participants
Interval 27.0 to 37.2
|
28.5 Percentage of participants
Interval 23.5 to 33.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
37.8 Percentage of participants
Interval 32.3 to 43.3
|
30.5 Percentage of participants
Interval 25.4 to 35.6
|
29.1 Percentage of participants
Interval 24.0 to 34.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
37.1 Percentage of participants
Interval 31.6 to 42.5
|
30.1 Percentage of participants
Interval 25.0 to 32.5
|
33.4 Percentage of participants
Interval 28.0 to 38.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
33.0 Percentage of participants
Interval 27.5 to 38.6
|
29.4 Percentage of participants
Interval 24.4 to 34.3
|
29.3 Percentage of participants
Interval 24.1 to 34.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
35.0 Percentage of participants
Interval 29.6 to 40.4
|
31.0 Percentage of participants
Interval 25.9 to 36.2
|
33.1 Percentage of participants
Interval 27.7 to 38.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
38.8 Percentage of participants
Interval 33.2 to 44.3
|
29.5 Percentage of participants
Interval 24.5 to 34.6
|
36.4 Percentage of participants
Interval 30.7 to 42.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
38.0 Percentage of participants
Interval 32.3 to 43.7
|
30.3 Percentage of participants
Interval 25.2 to 35.5
|
36.6 Percentage of participants
Interval 30.9 to 42.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
40.3 Percentage of participants
Interval 34.7 to 45.9
|
29.6 Percentage of participants
Interval 24.5 to 34.8
|
31.9 Percentage of participants
Interval 26.5 to 37.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
36.9 Percentage of participants
Interval 31.3 to 42.5
|
31.1 Percentage of participants
Interval 25.8 to 36.5
|
35.4 Percentage of participants
Interval 29.8 to 41.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
36.8 Percentage of participants
Interval 31.0 to 42.6
|
30.5 Percentage of participants
Interval 25.1 to 35.8
|
32.5 Percentage of participants
Interval 26.9 to 38.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
37.1 Percentage of participants
Interval 31.5 to 42.7
|
31.2 Percentage of participants
Interval 25.9 to 36.6
|
35.1 Percentage of participants
Interval 29.4 to 40.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
39.6 Percentage of participants
Interval 33.8 to 45.5
|
30.1 Percentage of participants
Interval 24.8 to 35.3
|
35.3 Percentage of participants
Interval 29.6 to 41.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
38.5 Percentage of participants
Interval 32.9 to 44.2
|
30.6 Percentage of participants
Interval 25.2 to 36.0
|
38.1 Percentage of participants
Interval 32.4 to 43.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
40.4 Percentage of participants
Interval 34.7 to 46.1
|
29.6 Percentage of participants
Interval 24.3 to 35.0
|
38.5 Percentage of participants
Interval 32.6 to 44.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
42.3 Percentage of participants
Interval 36.4 to 48.1
|
34.6 Percentage of participants
Interval 29.2 to 40.0
|
42.1 Percentage of participants
Interval 36.0 to 48.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
44.2 Percentage of participants
Interval 38.1 to 50.2
|
34.4 Percentage of participants
Interval 29.0 to 39.7
|
36.0 Percentage of participants
Interval 30.1 to 41.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
43.1 Percentage of participants
Interval 37.1 to 49.1
|
31.2 Percentage of participants
Interval 25.9 to 36.5
|
40.8 Percentage of participants
Interval 34.8 to 46.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
44.8 Percentage of participants
Interval 39.3 to 50.2
|
46.9 Percentage of participants
Interval 41.4 to 52.4
|
43.2 Percentage of participants
Interval 37.7 to 48.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
52.5 Percentage of participants
Interval 46.9 to 58.0
|
51.3 Percentage of participants
Interval 45.9 to 56.7
|
41.8 Percentage of participants
Interval 36.3 to 47.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
54.0 Percentage of participants
Interval 48.6 to 59.5
|
50.0 Percentage of participants
Interval 44.5 to 55.6
|
45.5 Percentage of participants
Interval 40.0 to 51.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
57.0 Percentage of participants
Interval 51.5 to 62.5
|
52.8 Percentage of participants
Interval 47.4 to 58.3
|
48.4 Percentage of participants
Interval 42.9 to 53.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
58.3 Percentage of participants
Interval 52.7 to 63.9
|
51.3 Percentage of participants
Interval 45.8 to 56.8
|
51.7 Percentage of participants
Interval 46.1 to 57.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
60.1 Percentage of participants
Interval 54.4 to 65.8
|
50.9 Percentage of participants
Interval 45.2 to 56.6
|
52.5 Percentage of participants
Interval 46.8 to 58.1
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
58.6 Percentage of participants
Interval 52.9 to 64.2
|
57.3 Percentage of participants
Interval 51.7 to 62.9
|
58.7 Percentage of participants
Interval 53.0 to 64.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
61.8 Percentage of participants
Interval 56.2 to 67.4
|
56.0 Percentage of participants
Interval 50.5 to 61.6
|
55.8 Percentage of participants
Interval 50.2 to 61.4
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
62.0 Percentage of participants
Interval 56.3 to 67.6
|
55.9 Percentage of participants
Interval 50.3 to 61.5
|
57.2 Percentage of participants
Interval 51.6 to 62.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
58.0 Percentage of participants
Interval 52.1 to 63.9
|
56.7 Percentage of participants
Interval 51.1 to 62.2
|
56.3 Percentage of participants
Interval 50.7 to 61.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
61.1 Percentage of participants
Interval 55.4 to 66.8
|
58.7 Percentage of participants
Interval 53.1 to 64.3
|
57.1 Percentage of participants
Interval 51.4 to 62.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
60.7 Percentage of participants
Interval 55.1 to 66.4
|
55.9 Percentage of participants
Interval 50.3 to 61.5
|
56.2 Percentage of participants
Interval 50.4 to 62.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
58.5 Percentage of participants
Interval 52.7 to 64.4
|
53.7 Percentage of participants
Interval 48.1 to 59.4
|
57.0 Percentage of participants
Interval 51.0 to 63.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
59.7 Percentage of participants
Interval 53.8 to 65.5
|
54.5 Percentage of participants
Interval 48.9 to 60.1
|
51.5 Percentage of participants
Interval 45.6 to 57.4
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
60.2 Percentage of participants
Interval 54.5 to 66.0
|
54.1 Percentage of participants
Interval 48.3 to 60.0
|
60.7 Percentage of participants
Interval 54.8 to 66.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
59.2 Percentage of participants
Interval 53.1 to 62.5
|
55.6 Percentage of participants
Interval 49.8 to 61.4
|
56.6 Percentage of participants
Interval 50.7 to 62.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
58.7 Percentage of participants
Interval 52.9 to 64.6
|
52.5 Percentage of participants
Interval 46.7 to 58.3
|
57.0 Percentage of participants
Interval 51.0 to 62.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
59.6 Percentage of participants
Interval 53.6 to 65.6
|
55.0 Percentage of participants
Interval 49.2 to 60.7
|
56.5 Percentage of participants
Interval 50.4 to 62.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
56.2 Percentage of participants
Interval 50.3 to 62.1
|
53.3 Percentage of participants
Interval 47.5 to 59.1
|
55.8 Percentage of participants
Interval 49.8 to 61.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
58.3 Percentage of participants
Interval 52.4 to 64.1
|
53.5 Percentage of participants
Interval 47.6 to 59.5
|
57.0 Percentage of participants
Interval 51.0 to 63.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
59.5 Percentage of participants
Interval 53.6 to 65.4
|
55.0 Percentage of participants
Interval 49.2 to 60.8
|
58.5 Percentage of participants
Interval 52.5 to 64.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
65.4 Percentage of participants
Interval 59.5 to 71.2
|
58.0 Percentage of participants
Interval 52.1 to 63.8
|
58.8 Percentage of participants
Interval 52.6 to 64.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
63.7 Percentage of participants
Interval 58.0 to 69.3
|
54.0 Percentage of participants
Interval 48.2 to 59.9
|
65.3 Percentage of participants
Interval 59.5 to 71.2
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
29.1 Percentage of participants
Interval 24.2 to 34.0
|
26.9 Percentage of participants
Interval 22.1 to 31.8
|
28.7 Percentage of participants
Interval 23.8 to 33.6
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
39.7 Percentage of participants
Interval 34.4 to 45.1
|
41.4 Percentage of participants
Interval 36.0 to 46.9
|
34.8 Percentage of participants
Interval 29.6 to 40.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
57.8 Percentage of participants
Interval 52.3 to 63.2
|
61.8 Percentage of participants
Interval 56.4 to 67.2
|
59.2 Percentage of participants
Interval 53.7 to 64.6
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
67.0 Percentage of participants
Interval 61.9 to 72.2
|
68.8 Percentage of participants
Interval 63.7 to 73.9
|
66.0 Percentage of participants
Interval 60.7 to 71.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
70.9 Percentage of participants
Interval 65.9 to 76.0
|
74.3 Percentage of participants
Interval 69.4 to 79.2
|
72.5 Percentage of participants
Interval 67.4 to 77.5
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
75.4 Percentage of participants
Interval 70.6 to 80.2
|
74.6 Percentage of participants
Interval 69.9 to 79.4
|
69.6 Percentage of participants
Interval 64.4 to 74.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
76.0 Percentage of participants
Interval 71.2 to 80.8
|
79.5 Percentage of participants
Interval 75.1 to 84.0
|
71.4 Percentage of participants
Interval 66.3 to 76.6
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
78.3 Percentage of participants
Interval 73.7 to 83.0
|
76.3 Percentage of participants
Interval 71.6 to 80.9
|
72.2 Percentage of participants
Interval 67.2 to 77.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
76.8 Percentage of participants
Interval 72.0 to 81.7
|
79.4 Percentage of participants
Interval 74.8 to 83.9
|
77.2 Percentage of participants
Interval 72.4 to 81.9
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
80.0 Percentage of participants
Interval 75.4 to 84.6
|
78.3 Percentage of participants
Interval 73.6 to 83.0
|
75.9 Percentage of participants
Interval 70.9 to 80.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
79.0 Percentage of participants
Interval 74.2 to 83.8
|
80.0 Percentage of participants
Interval 75.4 to 84.6
|
78.4 Percentage of participants
Interval 73.7 to 83.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
79.5 Percentage of participants
Interval 74.8 to 84.2
|
78.0 Percentage of participants
Interval 73.2 to 82.7
|
79.8 Percentage of participants
Interval 75.1 to 84.5
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
84.0 Percentage of participants
Interval 79.7 to 88.3
|
77.5 Percentage of participants
Interval 72.8 to 82.3
|
81.9 Percentage of participants
Interval 77.5 to 86.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
81.3 Percentage of participants
Interval 76.7 to 86.0
|
81.5 Percentage of participants
Interval 77.1 to 85.9
|
77.2 Percentage of participants
Interval 72.4 to 82.0
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
81.7 Percentage of participants
Interval 77.1 to 86.3
|
78.2 Percentage of participants
Interval 73.5 to 83.0
|
77.1 Percentage of participants
Interval 72.2 to 82.0
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
78.6 Percentage of participants
Interval 73.8 to 83.4
|
79.2 Percentage of participants
Interval 74.5 to 83.8
|
80.3 Percentage of participants
Interval 75.7 to 84.9
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
75.7 Percentage of participants
Interval 70.5 to 80.8
|
75.9 Percentage of participants
Interval 71.0 to 80.9
|
80.3 Percentage of participants
Interval 75.4 to 85.1
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
77.6 Percentage of participants
Interval 72.6 to 82.6
|
77.3 Percentage of participants
Interval 72.5 to 82.0
|
72.5 Percentage of participants
Interval 67.2 to 77.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
77.0 Percentage of participants
Interval 72.0 to 82.1
|
76.0 Percentage of participants
Interval 70.9 to 81.0
|
78.5 Percentage of participants
Interval 73.5 to 83.4
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
79.5 Percentage of participants
Interval 74.5 to 84.4
|
76.7 Percentage of participants
Interval 71.6 to 81.7
|
76.1 Percentage of participants
Interval 70.8 to 81.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
75.6 Percentage of participants
Interval 70.5 to 80.8
|
73.8 Percentage of participants
Interval 68.7 to 78.9
|
72.6 Percentage of participants
Interval 67.1 to 78.0
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
74.9 Percentage of participants
Interval 69.7 to 80.2
|
75.4 Percentage of participants
Interval 70.3 to 80.5
|
77.4 Percentage of participants
Interval 72.2 to 82.5
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
73.1 Percentage of participants
Interval 67.7 to 78.4
|
79.9 Percentage of participants
Interval 75.2 to 84.7
|
75.2 Percentage of participants
Interval 70.0 to 80.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
74.2 Percentage of participants
Interval 69.0 to 79.5
|
74.3 Percentage of participants
Interval 69.2 to 79.5
|
77.5 Percentage of participants
Interval 72.4 to 82.6
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
76.5 Percentage of participants
Interval 71.3 to 81.7
|
76.6 Percentage of participants
Interval 71.6 to 81.6
|
77.4 Percentage of participants
Interval 72.2 to 82.6
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
80.9 Percentage of participants
Interval 76.1 to 85.7
|
76.2 Percentage of participants
Interval 71.2 to 81.2
|
76.0 Percentage of participants
Interval 70.7 to 81.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
80.0 Percentage of participants
Interval 75.1 to 84.8
|
75.3 Percentage of participants
Interval 70.3 to 80.4
|
81.3 Percentage of participants
Interval 76.3 to 86.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
85.1 Percentage of participants
Interval 81.2 to 89.0
|
89.2 Percentage of participants
Interval 85.8 to 92.7
|
89.3 Percentage of participants
Interval 85.9 to 92.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
90.2 Percentage of participants
Interval 86.9 to 93.5
|
91.3 Percentage of participants
Interval 88.2 to 94.4
|
90.3 Percentage of participants
Interval 87.0 to 93.6
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
90.8 Percentage of participants
Interval 87.6 to 94.0
|
92.7 Percentage of participants
Interval 89.8 to 95.6
|
90.4 Percentage of participants
Interval 87.1 to 93.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
92.4 Percentage of participants
Interval 89.4 to 95.3
|
91.1 Percentage of participants
Interval 88.0 to 94.3
|
90.9 Percentage of participants
Interval 87.7 to 94.1
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
92.2 Percentage of participants
Interval 89.1 to 95.3
|
91.7 Percentage of participants
Interval 88.6 to 94.8
|
93.9 Percentage of participants
Interval 91.2 to 96.6
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
91.5 Percentage of participants
Interval 88.3 to 94.7
|
91.5 Percentage of participants
Interval 88.5 to 94.6
|
91.5 Percentage of participants
Interval 88.4 to 94.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
92.2 Percentage of participants
Interval 89.1 to 95.4
|
94.3 Percentage of participants
Interval 91.7 to 96.8
|
94.0 Percentage of participants
Interval 91.4 to 96.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
91.4 Percentage of participants
Interval 88.2 to 94.7
|
90.9 Percentage of participants
Interval 87.6 to 94.2
|
92.8 Percentage of participants
Interval 89.8 to 95.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
92.4 Percentage of participants
Interval 89.3 to 95.5
|
90.5 Percentage of participants
Interval 87.1 to 93.8
|
95.0 Percentage of participants
Interval 92.5 to 97.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
92.0 Percentage of participants
Interval 88.8 to 95.2
|
92.3 Percentage of participants
Interval 89.3 to 95.4
|
93.1 Percentage of participants
Interval 90.1 to 96.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
91.8 Percentage of participants
Interval 88.5 to 95.1
|
91.2 Percentage of participants
Interval 88.0 to 94.5
|
92.6 Percentage of participants
Interval 89.6 to 95.6
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
93.7 Percentage of participants
Interval 90.7 to 96.7
|
91.0 Percentage of participants
Interval 87.7 to 94.3
|
91.4 Percentage of participants
Interval 88.2 to 94.6
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
93.6 Percentage of participants
Interval 90.7 to 96.5
|
90.4 Percentage of participants
Interval 86.9 to 93.8
|
91.9 Percentage of participants
Interval 88.7 to 95.1
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
92.7 Percentage of participants
Interval 89.6 to 95.7
|
91.5 Percentage of participants
Interval 88.3 to 94.7
|
90.9 Percentage of participants
Interval 87.5 to 94.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
89.3 Percentage of participants
Interval 85.6 to 93.0
|
88.5 Percentage of participants
Interval 84.9 to 92.2
|
92.6 Percentage of participants
Interval 89.5 to 95.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
91.3 Percentage of participants
Interval 87.9 to 94.6
|
89.7 Percentage of participants
Interval 86.2 to 93.2
|
87.4 Percentage of participants
Interval 83.4 to 91.4
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
89.4 Percentage of participants
Interval 85.6 to 93.2
|
90.5 Percentage of participants
Interval 87.0 to 94.0
|
91.3 Percentage of participants
Interval 87.8 to 94.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
89.1 Percentage of participants
Interval 85.2 to 93.0
|
90.4 Percentage of participants
Interval 86.8 to 94.0
|
88.4 Percentage of participants
Interval 84.5 to 92.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
89.6 Percentage of participants
Interval 86.0 to 93.3
|
86.3 Percentage of participants
Interval 82.3 to 90.3
|
90.3 Percentage of participants
Interval 86.7 to 94.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
86.6 Percentage of participants
Interval 82.5 to 90.8
|
88.5 Percentage of participants
Interval 84.7 to 92.3
|
88.6 Percentage of participants
Interval 84.6 to 92.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
87.1 Percentage of participants
Interval 83.0 to 91.2
|
90.2 Percentage of participants
Interval 86.7 to 93.7
|
87.9 Percentage of participants
Interval 83.9 to 91.9
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
84.4 Percentage of participants
Interval 80.0 to 88.9
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
88.1 Percentage of participants
Interval 84.1 to 92.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
86.7 Percentage of participants
Interval 82.5 to 90.9
|
86.7 Percentage of participants
Interval 82.6 to 90.7
|
87.1 Percentage of participants
Interval 82.9 to 91.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
86.5 Percentage of participants
Interval 82.3 to 90.7
|
87.0 Percentage of participants
Interval 83.0 to 91.0
|
89.1 Percentage of participants
Interval 85.2 to 93.1
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
86.1 Percentage of participants
Interval 81.8 to 90.3
|
87.5 Percentage of participants
Interval 83.7 to 91.4
|
91.1 Percentage of participants
Interval 87.5 to 94.7
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=208 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=231 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=213 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Gaining ≥15 Letters
|
32.9 Percentage of participants
Interval 26.7 to 39.0
|
29.4 Percentage of participants
Interval 23.9 to 34.9
|
32.7 Percentage of participants
Interval 26.5 to 38.8
|
|
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Gaining ≥10 Letters
|
58.3 Percentage of participants
Interval 51.8 to 64.8
|
55.5 Percentage of participants
Interval 49.3 to 61.7
|
56.1 Percentage of participants
Interval 49.6 to 62.5
|
|
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Gaining ≥5 Letters
|
81.8 Percentage of participants
Interval 76.5 to 87.0
|
79.6 Percentage of participants
Interval 74.5 to 84.7
|
80.6 Percentage of participants
Interval 75.4 to 85.8
|
|
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Gaining ≥0 Letters
|
93.2 Percentage of participants
Interval 89.8 to 96.7
|
92.2 Percentage of participants
Interval 88.8 to 95.6
|
92.0 Percentage of participants
Interval 88.4 to 95.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
13.9 Percentage of participants
Interval 9.7 to 18.0
|
10.7 Percentage of participants
Interval 7.0 to 14.4
|
10.3 Percentage of participants
Interval 6.6 to 14.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
14.7 Percentage of participants
Interval 10.3 to 19.1
|
17.9 Percentage of participants
Interval 13.2 to 22.5
|
15.7 Percentage of participants
Interval 11.2 to 20.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
19.9 Percentage of participants
Interval 15.0 to 24.8
|
23.2 Percentage of participants
Interval 18.1 to 28.3
|
19.7 Percentage of participants
Interval 14.8 to 24.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
23.3 Percentage of participants
Interval 18.0 to 28.5
|
26.0 Percentage of participants
Interval 20.8 to 31.2
|
23.5 Percentage of participants
Interval 18.2 to 28.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
25.9 Percentage of participants
Interval 20.4 to 31.4
|
22.7 Percentage of participants
Interval 17.5 to 27.9
|
22.0 Percentage of participants
Interval 16.9 to 27.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
30.2 Percentage of participants
Interval 24.4 to 35.9
|
24.5 Percentage of participants
Interval 19.2 to 29.7
|
24.3 Percentage of participants
Interval 18.9 to 29.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
29.8 Percentage of participants
Interval 23.9 to 35.6
|
28.3 Percentage of participants
Interval 22.7 to 33.8
|
26.5 Percentage of participants
Interval 20.8 to 32.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
34.4 Percentage of participants
Interval 28.4 to 40.5
|
27.9 Percentage of participants
Interval 22.1 to 33.6
|
25.1 Percentage of participants
Interval 19.6 to 30.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
34.1 Percentage of participants
Interval 28.0 to 40.2
|
34.2 Percentage of participants
Interval 28.3 to 40.1
|
28.9 Percentage of participants
Interval 23.2 to 34.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
37.8 Percentage of participants
Interval 31.4 to 44.1
|
32.5 Percentage of participants
Interval 26.6 to 38.4
|
28.4 Percentage of participants
Interval 22.6 to 34.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
36.1 Percentage of participants
Interval 29.9 to 42.3
|
30.4 Percentage of participants
Interval 24.6 to 36.2
|
35.0 Percentage of participants
Interval 28.7 to 41.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
32.8 Percentage of participants
Interval 26.4 to 39.2
|
31.2 Percentage of participants
Interval 25.5 to 36.9
|
31.7 Percentage of participants
Interval 25.7 to 37.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
34.1 Percentage of participants
Interval 27.9 to 40.3
|
32.7 Percentage of participants
Interval 26.9 to 38.6
|
33.9 Percentage of participants
Interval 27.7 to 40.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
39.2 Percentage of participants
Interval 33.0 to 45.5
|
30.6 Percentage of participants
Interval 24.8 to 36.3
|
37.6 Percentage of participants
Interval 31.1 to 44.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
37.4 Percentage of participants
Interval 31.0 to 43.7
|
32.5 Percentage of participants
Interval 26.5 to 38.4
|
36.2 Percentage of participants
Interval 29.9 to 42.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
39.8 Percentage of participants
Interval 33.5 to 46.1
|
31.1 Percentage of participants
Interval 25.2 to 37.0
|
31.9 Percentage of participants
Interval 25.8 to 38.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
36.0 Percentage of participants
Interval 29.7 to 42.3
|
33.4 Percentage of participants
Interval 27.2 to 39.7
|
36.4 Percentage of participants
Interval 30.0 to 42.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
35.1 Percentage of participants
Interval 28.5 to 41.6
|
33.7 Percentage of participants
Interval 27.5 to 39.9
|
34.7 Percentage of participants
Interval 28.2 to 41.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
37.2 Percentage of participants
Interval 30.9 to 43.6
|
32.5 Percentage of participants
Interval 26.4 to 38.6
|
34.5 Percentage of participants
Interval 28.0 to 40.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
40.1 Percentage of participants
Interval 33.5 to 46.8
|
33.8 Percentage of participants
Interval 27.6 to 40.0
|
37.0 Percentage of participants
Interval 30.5 to 43.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
40.1 Percentage of participants
Interval 33.6 to 46.6
|
32.0 Percentage of participants
Interval 25.9 to 38.1
|
39.4 Percentage of participants
Interval 32.8 to 45.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
39.5 Percentage of participants
Interval 32.9 to 46.1
|
29.9 Percentage of participants
Interval 23.8 to 35.9
|
38.4 Percentage of participants
Interval 31.8 to 45.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
42.8 Percentage of participants
Interval 36.1 to 49.6
|
38.0 Percentage of participants
Interval 31.7 to 44.2
|
42.5 Percentage of participants
Interval 35.6 to 49.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
42.9 Percentage of participants
Interval 36.1 to 49.7
|
35.9 Percentage of participants
Interval 29.8 to 41.9
|
35.9 Percentage of participants
Interval 29.2 to 42.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
43.9 Percentage of participants
Interval 37.1 to 50.8
|
33.0 Percentage of participants
Interval 26.9 to 39.0
|
40.9 Percentage of participants
Interval 34.0 to 47.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
29.4 Percentage of participants
Interval 23.9 to 34.9
|
28.9 Percentage of participants
Interval 23.3 to 34.5
|
26.9 Percentage of participants
Interval 21.3 to 32.4
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
38.2 Percentage of participants
Interval 32.3 to 44.1
|
42.2 Percentage of participants
Interval 36.1 to 48.3
|
33.1 Percentage of participants
Interval 27.2 to 38.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
45.2 Percentage of participants
Interval 39.0 to 51.4
|
46.9 Percentage of participants
Interval 40.7 to 53.1
|
43.9 Percentage of participants
Interval 37.7 to 50.1
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
52.3 Percentage of participants
Interval 46.2 to 58.5
|
51.4 Percentage of participants
Interval 45.4 to 57.4
|
41.7 Percentage of participants
Interval 35.5 to 48.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
53.4 Percentage of participants
Interval 47.2 to 59.6
|
51.1 Percentage of participants
Interval 44.9 to 57.4
|
45.5 Percentage of participants
Interval 39.2 to 51.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
57.8 Percentage of participants
Interval 51.6 to 64.1
|
53.1 Percentage of participants
Interval 46.9 to 59.2
|
49.3 Percentage of participants
Interval 43.1 to 55.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
59.7 Percentage of participants
Interval 53.4 to 66.1
|
53.1 Percentage of participants
Interval 46.9 to 59.4
|
55.3 Percentage of participants
Interval 49.0 to 61.6
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
61.2 Percentage of participants
Interval 54.7 to 67.6
|
50.6 Percentage of participants
Interval 44.2 to 57.1
|
55.7 Percentage of participants
Interval 49.2 to 62.1
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
58.8 Percentage of participants
Interval 52.3 to 65.2
|
57.8 Percentage of participants
Interval 51.5 to 64.0
|
59.6 Percentage of participants
Interval 53.1 to 66.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
61.3 Percentage of participants
Interval 55.0 to 67.7
|
56.8 Percentage of participants
Interval 50.6 to 63.1
|
58.5 Percentage of participants
Interval 52.2 to 64.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
61.6 Percentage of participants
Interval 55.0 to 68.2
|
56.8 Percentage of participants
Interval 50.5 to 63.1
|
61.1 Percentage of participants
Interval 54.7 to 67.4
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
57.4 Percentage of participants
Interval 50.6 to 64.2
|
58.0 Percentage of participants
Interval 51.7 to 64.2
|
58.1 Percentage of participants
Interval 51.7 to 64.6
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
60.9 Percentage of participants
Interval 54.4 to 67.4
|
61.6 Percentage of participants
Interval 55.3 to 67.8
|
60.0 Percentage of participants
Interval 53.5 to 66.5
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
61.0 Percentage of participants
Interval 54.6 to 67.4
|
58.6 Percentage of participants
Interval 52.3 to 64.9
|
58.6 Percentage of participants
Interval 51.9 to 65.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
57.9 Percentage of participants
Interval 51.3 to 64.5
|
57.1 Percentage of participants
Interval 50.8 to 63.5
|
56.2 Percentage of participants
Interval 49.5 to 63.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
58.4 Percentage of participants
Interval 51.8 to 65.0
|
56.2 Percentage of participants
Interval 49.9 to 62.5
|
53.7 Percentage of participants
Interval 46.9 to 60.4
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
58.9 Percentage of participants
Interval 52.4 to 65.4
|
54.4 Percentage of participants
Interval 47.8 to 61.0
|
60.7 Percentage of participants
Interval 54.0 to 67.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
58.4 Percentage of participants
Interval 51.5 to 65.4
|
57.5 Percentage of participants
Interval 51.0 to 64.1
|
59.3 Percentage of participants
Interval 52.5 to 66.0
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
58.2 Percentage of participants
Interval 51.5 to 64.9
|
54.0 Percentage of participants
Interval 47.5 to 60.6
|
57.5 Percentage of participants
Interval 50.8 to 64.3
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
60.4 Percentage of participants
Interval 53.6 to 67.2
|
58.1 Percentage of participants
Interval 51.6 to 64.6
|
57.0 Percentage of participants
Interval 50.2 to 63.9
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
55.9 Percentage of participants
Interval 49.1 to 62.8
|
56.5 Percentage of participants
Interval 50.0 to 63.1
|
57.1 Percentage of participants
Interval 50.3 to 63.8
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
57.1 Percentage of participants
Interval 50.3 to 63.9
|
53.6 Percentage of participants
Interval 46.9 to 60.3
|
58.8 Percentage of participants
Interval 52.0 to 65.6
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
58.8 Percentage of participants
Interval 51.9 to 65.6
|
57.0 Percentage of participants
Interval 50.4 to 63.5
|
60.5 Percentage of participants
Interval 53.7 to 67.2
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
64.7 Percentage of participants
Interval 58.0 to 71.4
|
58.4 Percentage of participants
Interval 51.9 to 65.0
|
59.8 Percentage of participants
Interval 52.9 to 66.7
|
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
63.0 Percentage of participants
Interval 56.5 to 69.5
|
55.2 Percentage of participants
Interval 48.7 to 61.7
|
66.2 Percentage of participants
Interval 59.5 to 72.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
57.9 Percentage of participants
Interval 51.8 to 64.1
|
62.2 Percentage of participants
Interval 56.1 to 68.3
|
58.3 Percentage of participants
Interval 52.1 to 64.5
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
65.6 Percentage of participants
Interval 59.7 to 71.4
|
68.3 Percentage of participants
Interval 62.5 to 74.1
|
65.3 Percentage of participants
Interval 59.3 to 71.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
71.1 Percentage of participants
Interval 65.4 to 76.8
|
74.7 Percentage of participants
Interval 69.2 to 80.2
|
72.4 Percentage of participants
Interval 66.7 to 78.1
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
76.4 Percentage of participants
Interval 71.1 to 81.7
|
75.5 Percentage of participants
Interval 70.1 to 80.8
|
69.1 Percentage of participants
Interval 63.2 to 75.1
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
76.5 Percentage of participants
Interval 71.1 to 81.9
|
80.4 Percentage of participants
Interval 75.4 to 85.3
|
72.5 Percentage of participants
Interval 66.8 to 78.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
78.0 Percentage of participants
Interval 72.7 to 83.3
|
77.4 Percentage of participants
Interval 72.2 to 82.6
|
72.2 Percentage of participants
Interval 66.5 to 77.9
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
77.2 Percentage of participants
Interval 71.7 to 82.7
|
79.7 Percentage of participants
Interval 74.6 to 84.9
|
76.9 Percentage of participants
Interval 71.5 to 82.3
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
81.1 Percentage of participants
Interval 75.9 to 86.3
|
80.0 Percentage of participants
Interval 74.8 to 85.3
|
77.1 Percentage of participants
Interval 71.6 to 82.6
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
77.4 Percentage of participants
Interval 71.8 to 83.0
|
81.4 Percentage of participants
Interval 76.2 to 86.5
|
79.3 Percentage of participants
Interval 73.9 to 84.7
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
78.6 Percentage of participants
Interval 73.1 to 84.0
|
79.7 Percentage of participants
Interval 74.4 to 85.0
|
81.5 Percentage of participants
Interval 76.2 to 86.7
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
83.7 Percentage of participants
Interval 78.7 to 88.6
|
79.3 Percentage of participants
Interval 74.0 to 84.5
|
85.8 Percentage of participants
Interval 81.1 to 90.5
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
79.9 Percentage of participants
Interval 74.4 to 85.4
|
84.0 Percentage of participants
Interval 79.2 to 88.7
|
79.0 Percentage of participants
Interval 73.6 to 84.4
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
81.8 Percentage of participants
Interval 76.6 to 87.0
|
80.3 Percentage of participants
Interval 75.1 to 85.4
|
79.4 Percentage of participants
Interval 73.9 to 84.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
78.2 Percentage of participants
Interval 72.7 to 83.7
|
78.7 Percentage of participants
Interval 73.4 to 84.0
|
82.4 Percentage of participants
Interval 77.2 to 87.7
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
75.1 Percentage of participants
Interval 69.4 to 80.9
|
77.3 Percentage of participants
Interval 71.8 to 82.8
|
80.3 Percentage of participants
Interval 74.8 to 85.7
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
76.3 Percentage of participants
Interval 70.5 to 82.1
|
79.0 Percentage of participants
Interval 73.7 to 84.2
|
73.0 Percentage of participants
Interval 66.9 to 79.0
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
75.4 Percentage of participants
Interval 69.6 to 81.3
|
77.6 Percentage of participants
Interval 72.0 to 83.2
|
78.2 Percentage of participants
Interval 72.6 to 83.9
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
78.4 Percentage of participants
Interval 72.8 to 84.1
|
77.7 Percentage of participants
Interval 72.1 to 83.4
|
77.3 Percentage of participants
Interval 71.5 to 83.1
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
75.6 Percentage of participants
Interval 69.7 to 81.5
|
76.1 Percentage of participants
Interval 70.4 to 81.7
|
73.6 Percentage of participants
Interval 67.5 to 79.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
75.2 Percentage of participants
Interval 69.3 to 81.1
|
78.2 Percentage of participants
Interval 72.6 to 83.8
|
78.5 Percentage of participants
Interval 72.7 to 84.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
72.3 Percentage of participants
Interval 66.1 to 78.5
|
80.5 Percentage of participants
Interval 75.2 to 85.9
|
76.3 Percentage of participants
Interval 70.5 to 82.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
73.9 Percentage of participants
Interval 67.8 to 80.0
|
75.9 Percentage of participants
Interval 70.2 to 81.7
|
80.6 Percentage of participants
Interval 75.1 to 86.2
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
73.7 Percentage of participants
Interval 67.6 to 79.9
|
77.4 Percentage of participants
Interval 71.8 to 83.0
|
80.2 Percentage of participants
Interval 74.5 to 85.9
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
78.7 Percentage of participants
Interval 73.0 to 84.4
|
77.5 Percentage of participants
Interval 72.0 to 83.0
|
76.9 Percentage of participants
Interval 70.9 to 82.8
|
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
79.0 Percentage of participants
Interval 73.4 to 84.6
|
78.2 Percentage of participants
Interval 72.7 to 83.7
|
81.7 Percentage of participants
Interval 76.2 to 87.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
84.9 Percentage of participants
Interval 80.5 to 89.3
|
88.5 Percentage of participants
Interval 84.5 to 92.5
|
88.8 Percentage of participants
Interval 84.9 to 92.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
89.3 Percentage of participants
Interval 85.4 to 93.1
|
90.6 Percentage of participants
Interval 87.0 to 94.2
|
90.1 Percentage of participants
Interval 86.3 to 93.9
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
90.1 Percentage of participants
Interval 86.4 to 93.9
|
92.9 Percentage of participants
Interval 89.7 to 96.1
|
90.6 Percentage of participants
Interval 86.9 to 94.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
91.3 Percentage of participants
Interval 87.7 to 94.8
|
90.9 Percentage of participants
Interval 87.3 to 94.5
|
91.3 Percentage of participants
Interval 87.7 to 94.9
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
91.9 Percentage of participants
Interval 88.4 to 95.4
|
92.9 Percentage of participants
Interval 89.6 to 96.1
|
93.9 Percentage of participants
Interval 90.9 to 97.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
90.9 Percentage of participants
Interval 87.3 to 94.6
|
92.6 Percentage of participants
Interval 89.3 to 95.9
|
92.2 Percentage of participants
Interval 88.7 to 95.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
91.9 Percentage of participants
Interval 88.4 to 95.5
|
95.2 Percentage of participants
Interval 92.5 to 98.0
|
94.5 Percentage of participants
Interval 91.6 to 97.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
91.2 Percentage of participants
Interval 87.4 to 95.0
|
90.5 Percentage of participants
Interval 86.6 to 94.4
|
93.5 Percentage of participants
Interval 90.2 to 96.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
91.5 Percentage of participants
Interval 87.8 to 95.3
|
90.5 Percentage of participants
Interval 86.7 to 94.4
|
96.2 Percentage of participants
Interval 93.7 to 98.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
91.6 Percentage of participants
Interval 87.9 to 95.3
|
92.8 Percentage of participants
Interval 89.5 to 96.2
|
94.8 Percentage of participants
Interval 91.9 to 97.8
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
91.8 Percentage of participants
Interval 88.1 to 95.6
|
91.5 Percentage of participants
Interval 87.8 to 95.1
|
95.3 Percentage of participants
Interval 92.4 to 98.1
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
93.5 Percentage of participants
Interval 90.0 to 96.9
|
91.1 Percentage of participants
Interval 87.5 to 94.8
|
92.9 Percentage of participants
Interval 89.4 to 96.4
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
94.3 Percentage of participants
Interval 91.1 to 97.4
|
91.0 Percentage of participants
Interval 87.3 to 94.8
|
93.3 Percentage of participants
Interval 89.9 to 96.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
93.9 Percentage of participants
Interval 90.7 to 97.1
|
92.4 Percentage of participants
Interval 89.0 to 95.9
|
91.0 Percentage of participants
Interval 87.1 to 95.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
88.5 Percentage of participants
Interval 84.2 to 92.8
|
87.8 Percentage of participants
Interval 83.4 to 92.1
|
93.0 Percentage of participants
Interval 89.5 to 96.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
90.5 Percentage of participants
Interval 86.5 to 94.4
|
89.5 Percentage of participants
Interval 85.5 to 93.5
|
88.5 Percentage of participants
Interval 84.1 to 92.9
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
89.6 Percentage of participants
Interval 85.4 to 93.8
|
90.7 Percentage of participants
Interval 86.8 to 94.6
|
90.5 Percentage of participants
Interval 86.4 to 94.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
89.1 Percentage of participants
Interval 84.7 to 93.5
|
89.7 Percentage of participants
Interval 85.6 to 93.9
|
87.7 Percentage of participants
Interval 83.1 to 92.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
89.6 Percentage of participants
Interval 85.5 to 93.8
|
88.5 Percentage of participants
Interval 84.2 to 92.7
|
89.7 Percentage of participants
Interval 85.4 to 94.0
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
86.4 Percentage of participants
Interval 81.5 to 91.2
|
89.7 Percentage of participants
Interval 85.6 to 93.8
|
88.9 Percentage of participants
Interval 84.4 to 93.3
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
87.6 Percentage of participants
Interval 83.0 to 92.2
|
91.1 Percentage of participants
Interval 87.3 to 94.9
|
88.0 Percentage of participants
Interval 83.5 to 92.5
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
84.7 Percentage of participants
Interval 79.7 to 89.7
|
90.2 Percentage of participants
Interval 86.2 to 94.1
|
90.6 Percentage of participants
Interval 86.4 to 94.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
85.5 Percentage of participants
Interval 80.6 to 90.5
|
86.3 Percentage of participants
Interval 81.7 to 90.9
|
88.9 Percentage of participants
Interval 84.3 to 93.4
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
84.8 Percentage of participants
Interval 79.8 to 89.9
|
87.8 Percentage of participants
Interval 83.4 to 92.2
|
89.3 Percentage of participants
Interval 84.9 to 93.7
|
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
85.3 Percentage of participants
Interval 80.4 to 90.3
|
89.0 Percentage of participants
Interval 84.9 to 93.1
|
91.8 Percentage of participants
Interval 87.8 to 95.7
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=293 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Avoiding a Loss of ≥15 Letters
|
98.9 Percentage of participants
Interval 97.6 to 100.0
|
98.7 Percentage of participants
Interval 97.4 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Avoiding a Loss of ≥10 Letters
|
98.1 Percentage of participants
Interval 96.5 to 99.7
|
98.0 Percentage of participants
Interval 96.4 to 99.6
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Avoiding a Loss of ≥5 Letters
|
96.7 Percentage of participants
Interval 94.5 to 98.8
|
97.0 Percentage of participants
Interval 95.0 to 98.9
|
95.4 Percentage of participants
Interval 93.0 to 97.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
98.8 Percentage of participants
Interval 97.5 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.0 Percentage of participants
Interval 96.4 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
98.4 Percentage of participants
Interval 96.9 to 99.9
|
98.3 Percentage of participants
Interval 96.8 to 99.8
|
96.9 Percentage of participants
Interval 94.8 to 99.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
98.4 Percentage of participants
Interval 96.9 to 99.9
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.6 Percentage of participants
Interval 95.8 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
98.9 Percentage of participants
Interval 97.6 to 100.0
|
98.8 Percentage of participants
Interval 97.6 to 100.0
|
97.6 Percentage of participants
Interval 95.8 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
96.9 Percentage of participants
Interval 94.8 to 99.0
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.6 Percentage of participants
Interval 95.7 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
96.4 Percentage of participants
Interval 94.1 to 98.7
|
98.1 Percentage of participants
Interval 96.5 to 99.7
|
97.5 Percentage of participants
Interval 95.6 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
96.2 Percentage of participants
Interval 93.9 to 98.5
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
97.3 Percentage of participants
Interval 95.3 to 99.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
94.9 Percentage of participants
Interval 92.2 to 97.6
|
98.1 Percentage of participants
Interval 96.5 to 99.7
|
97.6 Percentage of participants
Interval 95.7 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
96.0 Percentage of participants
Interval 93.6 to 98.4
|
97.4 Percentage of participants
Interval 95.5 to 99.3
|
97.1 Percentage of participants
Interval 95.0 to 99.2
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
95.5 Percentage of participants
Interval 92.9 to 98.1
|
97.8 Percentage of participants
Interval 96.0 to 99.5
|
98.4 Percentage of participants
Interval 96.8 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
96.1 Percentage of participants
Interval 93.7 to 98.4
|
96.3 Percentage of participants
Interval 94.1 to 98.5
|
96.1 Percentage of participants
Interval 93.7 to 98.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
99.4 Percentage of participants
Interval 98.5 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
99.7 Percentage of participants
Interval 99.1 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.7 Percentage of participants
Interval 99.1 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
99.7 Percentage of participants
Interval 99.1 to 100.0
|
99.7 Percentage of participants
Interval 99.1 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
99.6 Percentage of participants
Interval 99.0 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
99.0 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.9 Percentage of participants
Interval 97.8 to 100.0
|
98.5 Percentage of participants
Interval 97.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
99.0 Percentage of participants
Interval 97.9 to 100.0
|
98.9 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
98.9 Percentage of participants
Interval 97.6 to 100.0
|
98.6 Percentage of participants
Interval 97.3 to 99.9
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.0 Percentage of participants
Interval 97.8 to 100.0
|
98.5 Percentage of participants
Interval 97.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
98.3 Percentage of participants
Interval 96.8 to 99.8
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
98.4 Percentage of participants
Interval 96.9 to 99.9
|
98.9 Percentage of participants
Interval 97.8 to 100.0
|
99.6 Percentage of participants
Interval 99.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
98.5 Percentage of participants
Interval 97.0 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
98.9 Percentage of participants
Interval 97.6 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
99.4 Percentage of participants
Interval 98.5 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
99.4 Percentage of participants
Interval 98.5 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
99.0 Percentage of participants
Interval 98.0 to 100.0
|
99.4 Percentage of participants
Interval 98.5 to 100.0
|
99.0 Percentage of participants
Interval 98.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
98.7 Percentage of participants
Interval 97.5 to 99.9
|
99.0 Percentage of participants
Interval 98.0 to 100.0
|
99.3 Percentage of participants
Interval 98.5 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
98.6 Percentage of participants
Interval 97.3 to 99.9
|
99.0 Percentage of participants
Interval 97.9 to 100.0
|
99.0 Percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
99.3 Percentage of participants
Interval 98.4 to 100.0
|
98.7 Percentage of participants
Interval 97.4 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
99.7 Percentage of participants
Interval 99.0 to 100.0
|
99.0 Percentage of participants
Interval 97.8 to 100.0
|
99.0 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.6 Percentage of participants
Interval 97.3 to 99.9
|
97.5 Percentage of participants
Interval 95.7 to 99.2
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.7 Percentage of participants
Interval 97.4 to 99.9
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
98.1 Percentage of participants
Interval 96.5 to 99.7
|
97.9 Percentage of participants
Interval 96.3 to 99.6
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
98.5 Percentage of participants
Interval 97.0 to 100.0
|
98.6 Percentage of participants
Interval 97.3 to 100.0
|
98.2 Percentage of participants
Interval 96.6 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
98.4 Percentage of participants
Interval 96.8 to 99.9
|
96.5 Percentage of participants
Interval 94.5 to 98.6
|
98.9 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
97.7 Percentage of participants
Interval 95.9 to 99.5
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
98.5 Percentage of participants
Interval 97.0 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
97.0 Percentage of participants
Interval 95.0 to 99.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
98.0 Percentage of participants
Interval 96.3 to 99.7
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
96.5 Percentage of participants
Interval 94.3 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
97.7 Percentage of participants
Interval 95.9 to 99.5
|
97.3 Percentage of participants
Interval 95.4 to 99.1
|
96.5 Percentage of participants
Interval 94.3 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
96.4 Percentage of participants
Interval 94.1 to 98.7
|
96.3 Percentage of participants
Interval 94.1 to 98.5
|
96.0 Percentage of participants
Interval 93.6 to 98.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
96.4 Percentage of participants
Interval 94.1 to 98.7
|
98.1 Percentage of participants
Interval 96.4 to 99.7
|
97.2 Percentage of participants
Interval 95.2 to 99.2
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
95.7 Percentage of participants
Interval 93.2 to 98.1
|
97.4 Percentage of participants
Interval 95.5 to 99.3
|
96.8 Percentage of participants
Interval 94.6 to 99.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
95.2 Percentage of participants
Interval 92.5 to 97.8
|
96.7 Percentage of participants
Interval 94.6 to 98.8
|
95.9 Percentage of participants
Interval 93.4 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
94.6 Percentage of participants
Interval 91.9 to 97.3
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
95.3 Percentage of participants
Interval 92.7 to 97.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
93.3 Percentage of participants
Interval 90.3 to 96.4
|
97.0 Percentage of participants
Interval 95.0 to 99.0
|
95.1 Percentage of participants
Interval 92.4 to 97.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
93.6 Percentage of participants
Interval 90.6 to 96.6
|
94.8 Percentage of participants
Interval 92.1 to 97.4
|
95.4 Percentage of participants
Interval 92.9 to 98.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
93.4 Percentage of participants
Interval 90.3 to 96.5
|
95.5 Percentage of participants
Interval 93.0 to 98.0
|
95.3 Percentage of participants
Interval 92.7 to 98.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
94.8 Percentage of participants
Interval 92.2 to 97.5
|
94.9 Percentage of participants
Interval 92.3 to 97.5
|
94.8 Percentage of participants
Interval 92.0 to 97.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 4
|
95.1 Percentage of participants
Interval 92.8 to 97.5
|
97.4 Percentage of participants
Interval 95.6 to 99.2
|
97.7 Percentage of participants
Interval 96.1 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 8
|
96.7 Percentage of participants
Interval 94.7 to 98.7
|
97.1 Percentage of participants
Interval 95.3 to 98.9
|
97.1 Percentage of participants
Interval 95.2 to 98.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 12
|
97.4 Percentage of participants
Interval 95.6 to 99.2
|
96.7 Percentage of participants
Interval 94.7 to 98.7
|
97.0 Percentage of participants
Interval 95.1 to 98.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 16
|
97.7 Percentage of participants
Interval 96.0 to 99.4
|
97.7 Percentage of participants
Interval 96.0 to 99.4
|
96.6 Percentage of participants
Interval 94.6 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 20
|
96.9 Percentage of participants
Interval 95.0 to 98.9
|
96.7 Percentage of participants
Interval 94.7 to 98.7
|
97.3 Percentage of participants
Interval 95.5 to 99.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 24
|
96.5 Percentage of participants
Interval 94.4 to 98.6
|
96.4 Percentage of participants
Interval 94.4 to 98.5
|
96.4 Percentage of participants
Interval 94.3 to 98.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 28
|
96.1 Percentage of participants
Interval 93.9 to 98.4
|
97.3 Percentage of participants
Interval 95.5 to 99.1
|
97.9 Percentage of participants
Interval 96.3 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 32
|
96.4 Percentage of participants
Interval 94.3 to 98.6
|
96.5 Percentage of participants
Interval 94.4 to 98.6
|
95.0 Percentage of participants
Interval 92.5 to 97.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 36
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
96.6 Percentage of participants
Interval 94.5 to 98.6
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 40
|
96.7 Percentage of participants
Interval 94.6 to 98.8
|
95.9 Percentage of participants
Interval 93.6 to 98.1
|
96.7 Percentage of participants
Interval 94.7 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 44
|
96.3 Percentage of participants
Interval 94.0 to 98.5
|
95.8 Percentage of participants
Interval 93.5 to 98.1
|
96.3 Percentage of participants
Interval 94.1 to 98.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 48
|
96.4 Percentage of participants
Interval 94.2 to 98.7
|
95.2 Percentage of participants
Interval 92.7 to 97.6
|
96.1 Percentage of participants
Interval 93.8 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 52
|
96.2 Percentage of participants
Interval 93.9 to 98.4
|
94.7 Percentage of participants
Interval 92.1 to 97.3
|
96.7 Percentage of participants
Interval 94.5 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 56
|
95.6 Percentage of participants
Interval 93.1 to 98.0
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
96.6 Percentage of participants
Interval 94.5 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 60
|
95.0 Percentage of participants
Interval 92.3 to 97.6
|
94.6 Percentage of participants
Interval 92.0 to 97.2
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 64
|
95.9 Percentage of participants
Interval 93.5 to 98.2
|
92.8 Percentage of participants
Interval 89.8 to 95.8
|
93.3 Percentage of participants
Interval 90.3 to 96.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 68
|
94.8 Percentage of participants
Interval 92.1 to 97.6
|
93.7 Percentage of participants
Interval 90.8 to 96.6
|
94.9 Percentage of participants
Interval 92.1 to 97.6
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 72
|
94.0 Percentage of participants
Interval 91.0 to 96.9
|
94.6 Percentage of participants
Interval 91.9 to 97.4
|
92.9 Percentage of participants
Interval 89.7 to 96.0
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 76
|
93.7 Percentage of participants
Interval 90.8 to 96.7
|
92.3 Percentage of participants
Interval 89.2 to 95.5
|
94.7 Percentage of participants
Interval 92.0 to 97.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 80
|
92.4 Percentage of participants
Interval 89.1 to 95.7
|
93.8 Percentage of participants
Interval 90.9 to 96.6
|
93.4 Percentage of participants
Interval 90.4 to 96.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 84
|
92.7 Percentage of participants
Interval 89.6 to 95.8
|
93.3 Percentage of participants
Interval 90.3 to 96.2
|
92.9 Percentage of participants
Interval 89.9 to 96.0
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 88
|
89.9 Percentage of participants
Interval 86.2 to 93.5
|
91.7 Percentage of participants
Interval 88.5 to 95.0
|
93.4 Percentage of participants
Interval 90.4 to 96.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 92
|
91.7 Percentage of participants
Interval 88.3 to 95.1
|
90.7 Percentage of participants
Interval 87.3 to 94.2
|
92.9 Percentage of participants
Interval 89.7 to 96.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 96
|
90.1 Percentage of participants
Interval 86.4 to 93.8
|
91.1 Percentage of participants
Interval 87.7 to 94.5
|
92.8 Percentage of participants
Interval 89.5 to 96.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Week 100
|
91.6 Percentage of participants
Interval 88.2 to 95.0
|
90.4 Percentage of participants
Interval 87.0 to 93.9
|
93.6 Percentage of participants
Interval 90.5 to 96.7
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=208 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=231 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=213 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Avoiding a Loss of ≥15 Letters
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
98.7 Percentage of participants
Interval 97.2 to 100.0
|
98.6 Percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Avoiding a Loss of ≥10 Letters
|
98.1 Percentage of participants
Interval 96.2 to 99.9
|
97.8 Percentage of participants
Interval 96.0 to 99.7
|
98.1 Percentage of participants
Interval 96.3 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Avoiding a Loss of ≥5 Letters
|
97.6 Percentage of participants
Interval 95.5 to 99.7
|
97.4 Percentage of participants
Interval 95.4 to 99.4
|
96.2 Percentage of participants
Interval 93.7 to 98.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.6 Percentage of participants
Interval 98.7 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.6 Percentage of participants
Interval 98.7 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.6 Percentage of participants
Interval 98.7 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
98.6 Percentage of participants
Interval 97.1 to 100.0
|
99.1 Percentage of participants
Interval 97.8 to 100.0
|
99.1 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
99.0 Percentage of participants
Interval 97.7 to 100.0
|
99.2 Percentage of participants
Interval 98.1 to 100.0
|
99.1 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
99.0 Percentage of participants
Interval 97.7 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
99.5 Percentage of participants
Interval 98.6 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
99.5 Percentage of participants
Interval 98.5 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
99.1 Percentage of participants
Interval 97.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
99.5 Percentage of participants
Interval 98.5 to 100.0
|
98.3 Percentage of participants
Interval 96.6 to 99.9
|
99.5 Percentage of participants
Interval 98.6 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
99.0 Percentage of participants
Interval 97.6 to 100.0
|
98.6 Percentage of participants
Interval 97.1 to 100.0
|
100.0 Percentage of participants
Interval 100.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
98.1 Percentage of participants
Interval 96.2 to 99.9
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
99.0 Percentage of participants
Interval 97.7 to 100.0
|
98.6 Percentage of participants
Interval 97.1 to 100.0
|
98.5 Percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
99.0 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.5 to 99.9
|
97.0 Percentage of participants
Interval 94.7 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
99.0 Percentage of participants
Interval 97.6 to 100.0
|
97.7 Percentage of participants
Interval 95.7 to 99.7
|
97.5 Percentage of participants
Interval 95.4 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
99.5 Percentage of participants
Interval 98.5 to 100.0
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
97.5 Percentage of participants
Interval 95.3 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
97.5 Percentage of participants
Interval 95.3 to 99.7
|
97.7 Percentage of participants
Interval 95.7 to 99.7
|
97.5 Percentage of participants
Interval 95.3 to 99.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
96.8 Percentage of participants
Interval 94.3 to 99.3
|
98.1 Percentage of participants
Interval 96.3 to 99.9
|
97.9 Percentage of participants
Interval 95.8 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
96.9 Percentage of participants
Interval 94.5 to 99.3
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
97.0 Percentage of participants
Interval 94.7 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
94.9 Percentage of participants
Interval 91.8 to 98.0
|
98.1 Percentage of participants
Interval 96.3 to 99.9
|
97.4 Percentage of participants
Interval 95.2 to 99.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
96.4 Percentage of participants
Interval 93.7 to 99.0
|
97.2 Percentage of participants
Interval 94.9 to 99.4
|
97.4 Percentage of participants
Interval 95.1 to 99.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
95.3 Percentage of participants
Interval 92.3 to 98.3
|
97.7 Percentage of participants
Interval 95.7 to 99.7
|
98.5 Percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
95.5 Percentage of participants
Interval 92.6 to 98.4
|
96.3 Percentage of participants
Interval 93.7 to 98.8
|
96.7 Percentage of participants
Interval 94.1 to 99.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.2 Percentage of participants
Interval 98.1 to 100.0
|
98.8 Percentage of participants
Interval 97.4 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
99.2 Percentage of participants
Interval 98.1 to 100.0
|
99.2 Percentage of participants
Interval 98.1 to 100.0
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
98.7 Percentage of participants
Interval 97.3 to 100.0
|
98.8 Percentage of participants
Interval 97.3 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
97.8 Percentage of participants
Interval 95.9 to 99.7
|
99.2 Percentage of participants
Interval 98.0 to 100.0
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
99.6 Percentage of participants
Interval 98.8 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
99.1 Percentage of participants
Interval 97.9 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
98.2 Percentage of participants
Interval 96.4 to 99.9
|
99.1 Percentage of participants
Interval 97.8 to 100.0
|
98.6 Percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
98.6 Percentage of participants
Interval 97.0 to 100.0
|
98.7 Percentage of participants
Interval 97.3 to 100.0
|
98.6 Percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
98.7 Percentage of participants
Interval 97.2 to 100.0
|
98.6 Percentage of participants
Interval 97.1 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
98.1 Percentage of participants
Interval 96.2 to 99.9
|
98.7 Percentage of participants
Interval 97.2 to 100.0
|
98.6 Percentage of participants
Interval 97.0 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
99.0 Percentage of participants
Interval 97.5 to 100.0
|
96.5 Percentage of participants
Interval 94.1 to 98.9
|
99.5 Percentage of participants
Interval 98.6 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
97.8 Percentage of participants
Interval 95.8 to 99.7
|
99.0 Percentage of participants
Interval 97.7 to 100.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
98.1 Percentage of participants
Interval 96.2 to 99.9
|
98.7 Percentage of participants
Interval 97.2 to 100.0
|
96.6 Percentage of participants
Interval 94.1 to 99.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
98.5 Percentage of participants
Interval 96.9 to 100.0
|
96.4 Percentage of participants
Interval 93.9 to 98.8
|
97.0 Percentage of participants
Interval 94.6 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
98.6 Percentage of participants
Interval 96.9 to 100.0
|
96.9 Percentage of participants
Interval 94.7 to 99.2
|
97.0 Percentage of participants
Interval 94.7 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
97.0 Percentage of participants
Interval 94.6 to 99.4
|
95.4 Percentage of participants
Interval 92.6 to 98.2
|
95.5 Percentage of participants
Interval 92.6 to 98.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
97.9 Percentage of participants
Interval 95.8 to 99.9
|
98.1 Percentage of participants
Interval 96.2 to 99.9
|
97.5 Percentage of participants
Interval 95.3 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
96.0 Percentage of participants
Interval 93.2 to 98.7
|
97.2 Percentage of participants
Interval 95.0 to 99.4
|
96.4 Percentage of participants
Interval 93.8 to 99.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
95.8 Percentage of participants
Interval 92.9 to 98.6
|
96.3 Percentage of participants
Interval 93.7 to 98.8
|
96.3 Percentage of participants
Interval 93.6 to 99.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
95.9 Percentage of participants
Interval 93.1 to 98.7
|
98.6 Percentage of participants
Interval 97.1 to 100.0
|
95.5 Percentage of participants
Interval 92.6 to 98.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
93.9 Percentage of participants
Interval 90.5 to 97.2
|
96.7 Percentage of participants
Interval 94.4 to 99.1
|
95.3 Percentage of participants
Interval 92.3 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
93.8 Percentage of participants
Interval 90.4 to 97.2
|
94.8 Percentage of participants
Interval 91.8 to 97.8
|
95.8 Percentage of participants
Interval 93.0 to 98.6
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
92.7 Percentage of participants
Interval 89.0 to 96.4
|
96.2 Percentage of participants
Interval 93.6 to 98.8
|
95.7 Percentage of participants
Interval 92.9 to 98.6
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
94.5 Percentage of participants
Interval 91.3 to 97.6
|
94.5 Percentage of participants
Interval 91.4 to 97.5
|
96.1 Percentage of participants
Interval 93.3 to 98.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
95.5 Percentage of participants
Interval 92.9 to 98.1
|
97.1 Percentage of participants
Interval 95.0 to 99.2
|
97.5 Percentage of participants
Interval 95.6 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
96.3 Percentage of participants
Interval 93.9 to 98.6
|
97.1 Percentage of participants
Interval 95.1 to 99.2
|
96.3 Percentage of participants
Interval 93.9 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
97.5 Percentage of participants
Interval 95.6 to 99.5
|
97.1 Percentage of participants
Interval 95.0 to 99.2
|
97.0 Percentage of participants
Interval 94.9 to 99.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
97.1 Percentage of participants
Interval 95.0 to 99.2
|
98.3 Percentage of participants
Interval 96.7 to 99.9
|
97.0 Percentage of participants
Interval 94.7 to 99.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
96.6 Percentage of participants
Interval 94.3 to 98.9
|
96.2 Percentage of participants
Interval 93.8 to 98.6
|
97.8 Percentage of participants
Interval 96.0 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
96.1 Percentage of participants
Interval 93.6 to 98.6
|
97.1 Percentage of participants
Interval 95.1 to 99.2
|
97.4 Percentage of participants
Interval 95.4 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
96.8 Percentage of participants
Interval 94.5 to 99.1
|
97.8 Percentage of participants
Interval 96.0 to 99.7
|
98.2 Percentage of participants
Interval 96.4 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
96.8 Percentage of participants
Interval 94.5 to 99.1
|
96.4 Percentage of participants
Interval 93.9 to 98.8
|
95.8 Percentage of participants
Interval 93.1 to 98.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
97.2 Percentage of participants
Interval 95.0 to 99.4
|
96.5 Percentage of participants
Interval 94.1 to 98.9
|
98.1 Percentage of participants
Interval 96.3 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
96.7 Percentage of participants
Interval 94.3 to 99.1
|
96.9 Percentage of participants
Interval 94.7 to 99.1
|
97.2 Percentage of participants
Interval 95.0 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
96.2 Percentage of participants
Interval 93.6 to 98.8
|
96.0 Percentage of participants
Interval 93.4 to 98.5
|
97.7 Percentage of participants
Interval 95.6 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
96.4 Percentage of participants
Interval 93.9 to 99.0
|
95.6 Percentage of participants
Interval 93.0 to 98.3
|
96.2 Percentage of participants
Interval 93.7 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
97.5 Percentage of participants
Interval 95.4 to 99.7
|
94.6 Percentage of participants
Interval 91.7 to 97.6
|
98.0 Percentage of participants
Interval 96.2 to 99.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
96.7 Percentage of participants
Interval 94.2 to 99.1
|
97.8 Percentage of participants
Interval 95.8 to 99.7
|
96.6 Percentage of participants
Interval 94.1 to 99.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
95.7 Percentage of participants
Interval 92.9 to 98.4
|
94.1 Percentage of participants
Interval 91.1 to 97.2
|
95.5 Percentage of participants
Interval 92.6 to 98.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
96.2 Percentage of participants
Interval 93.7 to 98.8
|
92.1 Percentage of participants
Interval 88.6 to 95.6
|
94.1 Percentage of participants
Interval 90.8 to 97.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
95.0 Percentage of participants
Interval 92.0 to 98.0
|
93.0 Percentage of participants
Interval 89.6 to 96.4
|
94.0 Percentage of participants
Interval 90.7 to 97.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
94.8 Percentage of participants
Interval 91.7 to 97.9
|
94.2 Percentage of participants
Interval 90.9 to 97.4
|
92.4 Percentage of participants
Interval 88.7 to 96.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
94.0 Percentage of participants
Interval 90.7 to 97.3
|
93.2 Percentage of participants
Interval 89.9 to 96.5
|
93.8 Percentage of participants
Interval 90.4 to 97.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
92.7 Percentage of participants
Interval 89.0 to 96.4
|
94.5 Percentage of participants
Interval 91.4 to 97.5
|
94.1 Percentage of participants
Interval 90.8 to 97.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
93.8 Percentage of participants
Interval 90.4 to 97.2
|
93.9 Percentage of participants
Interval 90.7 to 97.1
|
93.5 Percentage of participants
Interval 90.0 to 96.9
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
90.8 Percentage of participants
Interval 86.7 to 94.8
|
92.1 Percentage of participants
Interval 88.5 to 95.7
|
93.7 Percentage of participants
Interval 90.2 to 97.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
91.3 Percentage of participants
Interval 87.4 to 95.3
|
90.6 Percentage of participants
Interval 86.7 to 94.5
|
93.1 Percentage of participants
Interval 89.4 to 96.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
88.5 Percentage of participants
Interval 84.0 to 93.0
|
92.0 Percentage of participants
Interval 88.4 to 95.7
|
93.0 Percentage of participants
Interval 89.4 to 96.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
90.4 Percentage of participants
Interval 86.3 to 94.5
|
91.7 Percentage of participants
Interval 88.1 to 95.4
|
94.5 Percentage of participants
Interval 91.2 to 97.8
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=294 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
38.3 Percentage of participants
Interval 32.6 to 44.0
|
32.4 Percentage of participants
Interval 27.2 to 37.6
|
33.5 Percentage of participants
Interval 28.1 to 38.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
38.1 Percentage of participants
Interval 31.7 to 44.5
|
34.4 Percentage of participants
Interval 28.5 to 40.4
|
35.5 Percentage of participants
Interval 29.2 to 41.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 92
|
45.6 Percentage of participants
Interval 39.7 to 51.6
|
38.3 Percentage of participants
Interval 32.7 to 43.9
|
45.0 Percentage of participants
Interval 38.9 to 51.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 4
|
14.7 Percentage of participants
Interval 11.0 to 18.5
|
13.0 Percentage of participants
Interval 9.4 to 16.7
|
13.2 Percentage of participants
Interval 9.5 to 16.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 8
|
17.3 Percentage of participants
Interval 13.1 to 21.5
|
20.4 Percentage of participants
Interval 16.0 to 24.8
|
18.1 Percentage of participants
Interval 13.8 to 22.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 12
|
23.2 Percentage of participants
Interval 18.5 to 27.8
|
25.5 Percentage of participants
Interval 20.8 to 30.3
|
22.7 Percentage of participants
Interval 18.1 to 27.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 16
|
27.3 Percentage of participants
Interval 22.4 to 32.2
|
28.0 Percentage of participants
Interval 23.2 to 32.8
|
25.8 Percentage of participants
Interval 21.0 to 30.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 20
|
28.7 Percentage of participants
Interval 23.7 to 33.8
|
24.0 Percentage of participants
Interval 19.3 to 28.8
|
26.5 Percentage of participants
Interval 21.7 to 31.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 24
|
33.3 Percentage of participants
Interval 28.0 to 38.6
|
29.1 Percentage of participants
Interval 24.0 to 34.1
|
27.6 Percentage of participants
Interval 22.6 to 32.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 28
|
34.9 Percentage of participants
Interval 29.4 to 40.3
|
30.7 Percentage of participants
Interval 25.6 to 35.8
|
28.8 Percentage of participants
Interval 23.6 to 34.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 32
|
39.0 Percentage of participants
Interval 33.5 to 44.6
|
30.4 Percentage of participants
Interval 25.2 to 35.7
|
27.5 Percentage of participants
Interval 22.4 to 32.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 36
|
36.3 Percentage of participants
Interval 30.9 to 41.8
|
35.8 Percentage of participants
Interval 30.4 to 41.2
|
33.2 Percentage of participants
Interval 27.9 to 38.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 40
|
41.0 Percentage of participants
Interval 35.3 to 46.6
|
34.2 Percentage of participants
Interval 28.9 to 39.5
|
34.5 Percentage of participants
Interval 29.0 to 40.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 44
|
40.6 Percentage of participants
Interval 35.0 to 46.3
|
33.5 Percentage of participants
Interval 28.1 to 38.8
|
38.5 Percentage of participants
Interval 32.9 to 44.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 48
|
36.6 Percentage of participants
Interval 30.8 to 42.4
|
32.6 Percentage of participants
Interval 27.4 to 37.8
|
33.9 Percentage of participants
Interval 28.4 to 39.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 52
|
39.3 Percentage of participants
Interval 33.7 to 45.0
|
34.7 Percentage of participants
Interval 29.3 to 40.2
|
38.4 Percentage of participants
Interval 32.7 to 44.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 56
|
43.4 Percentage of participants
Interval 37.7 to 49.2
|
33.2 Percentage of participants
Interval 27.9 to 38.5
|
40.3 Percentage of participants
Interval 34.4 to 46.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 60
|
41.2 Percentage of participants
Interval 35.3 to 47.0
|
34.2 Percentage of participants
Interval 28.8 to 39.6
|
39.0 Percentage of participants
Interval 33.2 to 44.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 64
|
44.4 Percentage of participants
Interval 38.5 to 50.2
|
31.6 Percentage of participants
Interval 26.4 to 36.8
|
35.0 Percentage of participants
Interval 29.4 to 40.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 68
|
40.2 Percentage of participants
Interval 34.4 to 46.0
|
33.5 Percentage of participants
Interval 27.9 to 39.0
|
39.0 Percentage of participants
Interval 33.2 to 44.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 72
|
41.0 Percentage of participants
Interval 35.0 to 47.1
|
34.4 Percentage of participants
Interval 28.8 to 39.9
|
36.1 Percentage of participants
Interval 30.4 to 41.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 76
|
39.7 Percentage of participants
Interval 34.0 to 45.5
|
35.7 Percentage of participants
Interval 30.2 to 41.3
|
39.1 Percentage of participants
Interval 33.2 to 44.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 80
|
43.4 Percentage of participants
Interval 37.4 to 49.4
|
32.8 Percentage of participants
Interval 27.4 to 38.2
|
38.7 Percentage of participants
Interval 32.7 to 44.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 84
|
41.7 Percentage of participants
Interval 35.9 to 47.5
|
33.8 Percentage of participants
Interval 28.2 to 39.4
|
40.5 Percentage of participants
Interval 34.7 to 46.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 88
|
42.6 Percentage of participants
Interval 36.8 to 48.4
|
32.5 Percentage of participants
Interval 27.0 to 38.0
|
41.7 Percentage of participants
Interval 35.7 to 47.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 96
|
46.0 Percentage of participants
Interval 39.9 to 52.1
|
37.2 Percentage of participants
Interval 31.7 to 42.7
|
40.6 Percentage of participants
Interval 34.5 to 46.7
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Week 100
|
44.5 Percentage of participants
Interval 38.4 to 50.5
|
34.3 Percentage of participants
Interval 28.8 to 39.7
|
44.3 Percentage of participants
Interval 38.1 to 50.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
15.1 Percentage of participants
Interval 10.8 to 19.3
|
13.5 Percentage of participants
Interval 9.4 to 17.6
|
12.8 Percentage of participants
Interval 8.6 to 17.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
17.0 Percentage of participants
Interval 12.4 to 21.7
|
22.2 Percentage of participants
Interval 17.0 to 27.3
|
17.7 Percentage of participants
Interval 13.0 to 22.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
22.6 Percentage of participants
Interval 17.4 to 27.8
|
26.3 Percentage of participants
Interval 21.0 to 31.6
|
22.7 Percentage of participants
Interval 17.6 to 27.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
26.1 Percentage of participants
Interval 20.6 to 31.5
|
30.0 Percentage of participants
Interval 24.4 to 35.5
|
26.1 Percentage of participants
Interval 20.6 to 31.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
28.4 Percentage of participants
Interval 22.7 to 34.1
|
26.2 Percentage of participants
Interval 20.7 to 31.7
|
25.9 Percentage of participants
Interval 20.5 to 31.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
34.2 Percentage of participants
Interval 28.2 to 40.3
|
30.5 Percentage of participants
Interval 24.8 to 36.3
|
27.3 Percentage of participants
Interval 21.7 to 32.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
35.4 Percentage of participants
Interval 29.1 to 41.6
|
32.9 Percentage of participants
Interval 27.0 to 38.9
|
29.6 Percentage of participants
Interval 23.7 to 35.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
38.4 Percentage of participants
Interval 32.0 to 44.7
|
31.5 Percentage of participants
Interval 25.5 to 37.5
|
28.9 Percentage of participants
Interval 23.0 to 34.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
37.0 Percentage of participants
Interval 30.7 to 43.3
|
38.0 Percentage of participants
Interval 31.9 to 44.2
|
34.6 Percentage of participants
Interval 28.5 to 40.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
41.4 Percentage of participants
Interval 34.9 to 47.8
|
36.4 Percentage of participants
Interval 30.2 to 42.5
|
34.6 Percentage of participants
Interval 28.3 to 40.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
40.3 Percentage of participants
Interval 33.8 to 46.7
|
34.3 Percentage of participants
Interval 28.2 to 40.4
|
40.7 Percentage of participants
Interval 34.2 to 47.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
36.7 Percentage of participants
Interval 30.1 to 43.4
|
34.9 Percentage of participants
Interval 28.9 to 40.9
|
36.5 Percentage of participants
Interval 30.1 to 42.9
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
39.1 Percentage of participants
Interval 32.6 to 45.6
|
37.0 Percentage of participants
Interval 30.8 to 43.2
|
39.8 Percentage of participants
Interval 33.2 to 46.4
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
44.7 Percentage of participants
Interval 38.1 to 51.2
|
35.2 Percentage of participants
Interval 29.1 to 41.3
|
41.7 Percentage of participants
Interval 35.0 to 48.5
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
40.9 Percentage of participants
Interval 34.3 to 47.5
|
36.9 Percentage of participants
Interval 30.6 to 43.2
|
39.2 Percentage of participants
Interval 32.7 to 45.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
44.0 Percentage of participants
Interval 37.4 to 50.6
|
33.6 Percentage of participants
Interval 27.5 to 39.7
|
35.4 Percentage of participants
Interval 29.0 to 41.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
39.7 Percentage of participants
Interval 33.2 to 46.2
|
35.5 Percentage of participants
Interval 29.1 to 41.9
|
40.0 Percentage of participants
Interval 33.4 to 46.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
40.0 Percentage of participants
Interval 33.1 to 46.8
|
37.7 Percentage of participants
Interval 31.2 to 44.2
|
38.3 Percentage of participants
Interval 31.7 to 45.0
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
40.6 Percentage of participants
Interval 34.0 to 47.2
|
37.8 Percentage of participants
Interval 31.4 to 44.2
|
39.1 Percentage of participants
Interval 32.4 to 45.8
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
44.9 Percentage of participants
Interval 38.0 to 51.8
|
37.3 Percentage of participants
Interval 30.9 to 43.7
|
40.9 Percentage of participants
Interval 34.1 to 47.6
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
43.1 Percentage of participants
Interval 36.5 to 49.8
|
36.0 Percentage of participants
Interval 29.6 to 42.4
|
41.4 Percentage of participants
Interval 34.8 to 48.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
42.3 Percentage of participants
Interval 35.6 to 49.1
|
33.5 Percentage of participants
Interval 27.2 to 39.8
|
41.5 Percentage of participants
Interval 34.7 to 48.2
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
47.1 Percentage of participants
Interval 40.2 to 54.0
|
42.6 Percentage of participants
Interval 36.1 to 49.2
|
45.2 Percentage of participants
Interval 38.2 to 52.1
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
44.6 Percentage of participants
Interval 37.7 to 51.5
|
39.5 Percentage of participants
Interval 33.1 to 45.8
|
41.4 Percentage of participants
Interval 34.4 to 48.3
|
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
45.6 Percentage of participants
Interval 38.7 to 52.5
|
36.9 Percentage of participants
Interval 30.6 to 43.2
|
44.9 Percentage of participants
Interval 37.8 to 52.0
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=293 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
73.2 Percentage of participants
Interval 68.2 to 78.3
|
71.6 Percentage of participants
Interval 66.7 to 76.4
|
68.5 Percentage of participants
Interval 63.6 to 73.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
73.6 Percentage of participants
Interval 68.0 to 79.3
|
74.2 Percentage of participants
Interval 68.9 to 79.5
|
72.1 Percentage of participants
Interval 66.6 to 77.7
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 4
|
56.7 Percentage of participants
Interval 51.6 to 61.7
|
57.8 Percentage of participants
Interval 53.2 to 62.4
|
54.4 Percentage of participants
Interval 49.7 to 59.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 8
|
61.3 Percentage of participants
Interval 56.4 to 66.2
|
65.7 Percentage of participants
Interval 61.1 to 70.3
|
59.4 Percentage of participants
Interval 54.7 to 64.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 12
|
68.0 Percentage of participants
Interval 63.2 to 72.8
|
67.8 Percentage of participants
Interval 63.2 to 72.4
|
65.2 Percentage of participants
Interval 60.4 to 70.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 16
|
66.8 Percentage of participants
Interval 61.9 to 71.7
|
69.2 Percentage of participants
Interval 64.6 to 73.7
|
64.6 Percentage of participants
Interval 59.7 to 69.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 20
|
69.6 Percentage of participants
Interval 64.8 to 74.5
|
67.3 Percentage of participants
Interval 62.5 to 72.0
|
66.0 Percentage of participants
Interval 61.2 to 70.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 24
|
70.6 Percentage of participants
Interval 65.7 to 75.6
|
69.1 Percentage of participants
Interval 64.4 to 73.8
|
65.5 Percentage of participants
Interval 60.6 to 70.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 28
|
72.0 Percentage of participants
Interval 67.1 to 76.9
|
69.9 Percentage of participants
Interval 65.2 to 74.5
|
67.0 Percentage of participants
Interval 62.2 to 71.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 32
|
72.6 Percentage of participants
Interval 67.6 to 77.7
|
71.9 Percentage of participants
Interval 67.1 to 76.7
|
67.3 Percentage of participants
Interval 62.4 to 72.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 36
|
71.4 Percentage of participants
Interval 66.3 to 76.4
|
69.6 Percentage of participants
Interval 64.6 to 74.5
|
70.1 Percentage of participants
Interval 65.2 to 75.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 40
|
73.8 Percentage of participants
Interval 68.9 to 78.6
|
70.8 Percentage of participants
Interval 65.9 to 75.6
|
70.4 Percentage of participants
Interval 65.4 to 75.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 44
|
73.7 Percentage of participants
Interval 68.7 to 78.8
|
71.1 Percentage of participants
Interval 66.3 to 75.9
|
69.0 Percentage of participants
Interval 64.0 to 73.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 48
|
73.1 Percentage of participants
Interval 67.8 to 78.3
|
73.0 Percentage of participants
Interval 68.1 to 77.9
|
67.1 Percentage of participants
Interval 62.1 to 72.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 52
|
74.5 Percentage of participants
Interval 69.5 to 79.5
|
69.8 Percentage of participants
Interval 64.8 to 74.8
|
71.0 Percentage of participants
Interval 66.1 to 75.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 56
|
74.7 Percentage of participants
Interval 69.7 to 79.8
|
73.4 Percentage of participants
Interval 68.6 to 78.2
|
71.9 Percentage of participants
Interval 66.8 to 76.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 60
|
70.3 Percentage of participants
Interval 64.9 to 75.7
|
67.1 Percentage of participants
Interval 62.0 to 72.3
|
69.4 Percentage of participants
Interval 64.3 to 74.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 64
|
74.5 Percentage of participants
Interval 69.5 to 79.6
|
68.1 Percentage of participants
Interval 63.0 to 73.2
|
68.2 Percentage of participants
Interval 63.0 to 73.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 68
|
71.9 Percentage of participants
Interval 66.6 to 77.2
|
68.4 Percentage of participants
Interval 63.2 to 73.6
|
72.3 Percentage of participants
Interval 67.2 to 77.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 72
|
68.8 Percentage of participants
Interval 63.2 to 74.3
|
72.2 Percentage of participants
Interval 67.2 to 77.3
|
66.2 Percentage of participants
Interval 60.8 to 71.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 76
|
70.1 Percentage of participants
Interval 64.8 to 75.5
|
69.0 Percentage of participants
Interval 63.9 to 74.2
|
70.7 Percentage of participants
Interval 65.3 to 76.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 80
|
72.4 Percentage of participants
Interval 67.0 to 77.8
|
70.9 Percentage of participants
Interval 65.8 to 76.0
|
69.5 Percentage of participants
Interval 64.0 to 74.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 84
|
72.7 Percentage of participants
Interval 67.4 to 78.0
|
71.6 Percentage of participants
Interval 66.5 to 76.8
|
71.4 Percentage of participants
Interval 66.0 to 76.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 88
|
68.7 Percentage of participants
Interval 63.3 to 74.2
|
70.3 Percentage of participants
Interval 65.1 to 75.5
|
71.3 Percentage of participants
Interval 65.9 to 76.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 92
|
71.6 Percentage of participants
Interval 66.1 to 77.0
|
73.5 Percentage of participants
Interval 68.4 to 78.6
|
69.5 Percentage of participants
Interval 64.0 to 74.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 96
|
74.9 Percentage of participants
Interval 69.5 to 80.3
|
73.1 Percentage of participants
Interval 68.0 to 78.2
|
73.2 Percentage of participants
Interval 67.9 to 78.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Week 100
|
73.5 Percentage of participants
Interval 68.1 to 78.9
|
70.0 Percentage of participants
Interval 64.8 to 75.1
|
76.4 Percentage of participants
Interval 71.2 to 81.6
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. \<69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
57.5 Percentage of participants
Interval 51.9 to 63.1
|
59.9 Percentage of participants
Interval 54.8 to 64.9
|
56.0 Percentage of participants
Interval 50.7 to 61.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
62.3 Percentage of participants
Interval 56.8 to 67.7
|
67.0 Percentage of participants
Interval 61.9 to 72.1
|
59.9 Percentage of participants
Interval 54.5 to 65.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
68.9 Percentage of participants
Interval 63.6 to 74.1
|
70.2 Percentage of participants
Interval 65.1 to 75.3
|
67.5 Percentage of participants
Interval 62.1 to 73.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
66.8 Percentage of participants
Interval 61.3 to 72.3
|
70.7 Percentage of participants
Interval 65.7 to 75.7
|
65.0 Percentage of participants
Interval 59.4 to 70.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
70.2 Percentage of participants
Interval 64.7 to 75.6
|
69.2 Percentage of participants
Interval 64.0 to 74.3
|
67.4 Percentage of participants
Interval 62.1 to 72.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
71.1 Percentage of participants
Interval 65.6 to 76.5
|
71.7 Percentage of participants
Interval 66.6 to 76.8
|
66.2 Percentage of participants
Interval 60.8 to 71.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
73.5 Percentage of participants
Interval 68.1 to 79.0
|
71.0 Percentage of participants
Interval 65.9 to 76.1
|
69.4 Percentage of participants
Interval 64.0 to 74.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
74.3 Percentage of participants
Interval 68.7 to 80.0
|
74.8 Percentage of participants
Interval 69.4 to 80.1
|
70.2 Percentage of participants
Interval 64.6 to 75.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
71.8 Percentage of participants
Interval 66.0 to 77.5
|
71.2 Percentage of participants
Interval 65.6 to 76.8
|
72.4 Percentage of participants
Interval 66.9 to 77.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
74.0 Percentage of participants
Interval 68.6 to 79.5
|
73.7 Percentage of participants
Interval 68.4 to 79.0
|
72.3 Percentage of participants
Interval 66.7 to 77.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
73.8 Percentage of participants
Interval 68.1 to 79.4
|
74.3 Percentage of participants
Interval 69.1 to 79.6
|
73.5 Percentage of participants
Interval 68.0 to 78.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
73.1 Percentage of participants
Interval 67.3 to 79.0
|
76.2 Percentage of participants
Interval 70.9 to 81.5
|
70.5 Percentage of participants
Interval 65.0 to 75.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
73.9 Percentage of participants
Interval 68.2 to 79.5
|
73.3 Percentage of participants
Interval 67.7 to 78.8
|
75.5 Percentage of participants
Interval 70.1 to 80.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
75.9 Percentage of participants
Interval 70.3 to 81.5
|
75.5 Percentage of participants
Interval 70.3 to 80.7
|
74.7 Percentage of participants
Interval 69.1 to 80.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
69.9 Percentage of participants
Interval 63.9 to 76.0
|
70.9 Percentage of participants
Interval 65.2 to 76.7
|
71.5 Percentage of participants
Interval 65.8 to 77.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
73.7 Percentage of participants
Interval 67.9 to 79.4
|
70.6 Percentage of participants
Interval 65.0 to 76.2
|
70.4 Percentage of participants
Interval 64.5 to 76.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
71.8 Percentage of participants
Interval 65.8 to 77.7
|
68.4 Percentage of participants
Interval 62.5 to 74.3
|
73.9 Percentage of participants
Interval 68.2 to 79.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
67.0 Percentage of participants
Interval 60.6 to 73.3
|
73.9 Percentage of participants
Interval 68.2 to 79.6
|
68.6 Percentage of participants
Interval 62.6 to 74.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
70.3 Percentage of participants
Interval 64.1 to 76.4
|
72.1 Percentage of participants
Interval 66.4 to 77.8
|
71.7 Percentage of participants
Interval 65.7 to 77.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
73.2 Percentage of participants
Interval 67.0 to 79.3
|
72.5 Percentage of participants
Interval 66.8 to 78.3
|
72.6 Percentage of participants
Interval 66.6 to 78.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
73.4 Percentage of participants
Interval 67.4 to 79.4
|
72.2 Percentage of participants
Interval 66.4 to 78.0
|
72.5 Percentage of participants
Interval 66.6 to 78.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
68.1 Percentage of participants
Interval 62.0 to 74.3
|
70.4 Percentage of participants
Interval 64.5 to 76.2
|
75.3 Percentage of participants
Interval 69.3 to 81.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
70.5 Percentage of participants
Interval 64.2 to 76.8
|
74.5 Percentage of participants
Interval 68.6 to 80.4
|
73.2 Percentage of participants
Interval 67.2 to 79.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
72.7 Percentage of participants
Interval 66.4 to 79.0
|
74.8 Percentage of participants
Interval 69.1 to 80.5
|
73.8 Percentage of participants
Interval 67.9 to 79.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
71.2 Percentage of participants
Interval 64.9 to 77.4
|
70.7 Percentage of participants
Interval 64.8 to 76.6
|
77.7 Percentage of participants
Interval 71.9 to 83.5
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 48, 52, and 56Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=294 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
0.8 Percentage of participants
Interval 0.0 to 1.8
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.7 Percentage of participants
Interval 0.0 to 1.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
1.0 Percentage of participants
Interval 0.0 to 2.3
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 4
|
1.6 Percentage of participants
Interval 0.2 to 3.0
|
1.7 Percentage of participants
Interval 0.2 to 3.1
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 8
|
1.3 Percentage of participants
Interval 0.0 to 2.6
|
0.6 Percentage of participants
Interval 0.0 to 1.5
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 12
|
1.3 Percentage of participants
Interval 0.1 to 2.6
|
0.7 Percentage of participants
Interval 0.0 to 1.6
|
0.6 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 16
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.3 Percentage of participants
Interval 0.0 to 0.9
|
0.7 Percentage of participants
Interval 0.0 to 1.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 20
|
1.0 Percentage of participants
Interval 0.0 to 2.2
|
0.3 Percentage of participants
Interval 0.0 to 0.9
|
1.0 Percentage of participants
Interval 0.0 to 2.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 24
|
0.7 Percentage of participants
Interval 0.0 to 1.7
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
1.3 Percentage of participants
Interval 0.1 to 2.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 28
|
1.1 Percentage of participants
Interval 0.0 to 2.2
|
0.3 Percentage of participants
Interval 0.0 to 1.0
|
0.7 Percentage of participants
Interval 0.0 to 1.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 32
|
0.7 Percentage of participants
Interval 0.0 to 1.7
|
1.4 Percentage of participants
Interval 0.1 to 2.8
|
1.1 Percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 36
|
0.7 Percentage of participants
Interval 0.0 to 1.7
|
1.3 Percentage of participants
Interval 0.1 to 2.6
|
0.4 Percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 40
|
1.1 Percentage of participants
Interval 0.0 to 2.4
|
1.4 Percentage of participants
Interval 0.1 to 2.7
|
1.1 Percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 44
|
0.4 Percentage of participants
Interval 0.0 to 1.1
|
1.0 Percentage of participants
Interval 0.0 to 2.2
|
1.1 Percentage of participants
Interval 0.0 to 2.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 48
|
0.8 Percentage of participants
Interval 0.0 to 1.9
|
0.7 Percentage of participants
Interval 0.0 to 1.6
|
1.4 Percentage of participants
Interval 0.1 to 2.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 52
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.4 Percentage of participants
Interval 0.0 to 1.1
|
1.1 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 56
|
1.1 Percentage of participants
Interval 0.0 to 2.4
|
1.0 Percentage of participants
Interval 0.0 to 2.2
|
0.8 Percentage of participants
Interval 0.0 to 1.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 60
|
1.2 Percentage of participants
Interval 0.0 to 2.5
|
0.7 Percentage of participants
Interval 0.0 to 1.7
|
1.5 Percentage of participants
Interval 0.1 to 2.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 64
|
1.2 Percentage of participants
Interval 0.0 to 2.4
|
0.7 Percentage of participants
Interval 0.0 to 1.6
|
2.0 Percentage of participants
Interval 0.3 to 3.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 68
|
1.2 Percentage of participants
Interval 0.0 to 2.5
|
1.1 Percentage of participants
Interval 0.0 to 2.4
|
0.4 Percentage of participants
Interval 0.0 to 1.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 72
|
1.2 Percentage of participants
Interval 0.0 to 2.5
|
1.9 Percentage of participants
Interval 0.3 to 3.6
|
1.5 Percentage of participants
Interval 0.1 to 3.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 76
|
2.7 Percentage of participants
Interval 0.8 to 4.7
|
1.8 Percentage of participants
Interval 0.2 to 3.4
|
2.0 Percentage of participants
Interval 0.3 to 3.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 80
|
2.4 Percentage of participants
Interval 0.6 to 4.3
|
2.6 Percentage of participants
Interval 0.7 to 4.6
|
1.6 Percentage of participants
Interval 0.1 to 3.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 84
|
2.7 Percentage of participants
Interval 0.7 to 4.6
|
1.2 Percentage of participants
Interval 0.0 to 2.5
|
1.9 Percentage of participants
Interval 0.3 to 3.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 88
|
2.3 Percentage of participants
Interval 0.5 to 4.1
|
1.9 Percentage of participants
Interval 0.3 to 3.4
|
1.2 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 92
|
3.2 Percentage of participants
Interval 1.0 to 5.4
|
0.8 Percentage of participants
Interval 0.0 to 1.8
|
1.6 Percentage of participants
Interval 0.1 to 3.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 96
|
2.9 Percentage of participants
Interval 0.8 to 5.0
|
2.3 Percentage of participants
Interval 0.5 to 4.1
|
2.0 Percentage of participants
Interval 0.3 to 3.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Week 100
|
2.7 Percentage of participants
Interval 0.7 to 4.7
|
3.3 Percentage of participants
Interval 1.2 to 5.5
|
2.5 Percentage of participants
Interval 0.5 to 4.4
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
0.9 Percentage of participants
Interval 0.0 to 2.2
|
1.4 Percentage of participants
Interval 0.0 to 2.9
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
1.0 Percentage of participants
Interval 0.0 to 2.3
|
1.7 Percentage of participants
Interval 0.1 to 3.4
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
1.0 Percentage of participants
Interval 0.0 to 2.2
|
1.8 Percentage of participants
Interval 0.1 to 3.5
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
2.0 Percentage of participants
Interval 0.3 to 3.8
|
1.7 Percentage of participants
Interval 0.1 to 3.2
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
1.6 Percentage of participants
Interval 0.1 to 3.2
|
0.8 Percentage of participants
Interval 0.0 to 1.9
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
1.2 Percentage of participants
Interval 0.0 to 2.6
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.8 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.9 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
0.9 Percentage of participants
Interval 0.0 to 2.1
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.9 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
0.9 Percentage of participants
Interval 0.0 to 2.1
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.8 Percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
1.3 Percentage of participants
Interval 0.0 to 2.8
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
1.3 Percentage of participants
Interval 0.0 to 2.8
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
1.0 Percentage of participants
Interval 0.0 to 2.4
|
0.9 Percentage of participants
Interval 0.0 to 2.1
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
1.4 Percentage of participants
Interval 0.0 to 3.0
|
0.9 Percentage of participants
Interval 0.0 to 2.0
|
1.0 Percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
0.9 Percentage of participants
Interval 0.0 to 2.2
|
0.9 Percentage of participants
Interval 0.0 to 2.2
|
1.0 Percentage of participants
Interval 0.0 to 2.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
0.9 Percentage of participants
Interval 0.0 to 2.0
|
2.0 Percentage of participants
Interval 0.1 to 4.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
0.5 Percentage of participants
Interval 0.0 to 1.5
|
1.4 Percentage of participants
Interval 0.0 to 3.0
|
0.5 Percentage of participants
Interval 0.0 to 1.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
1.0 Percentage of participants
Interval 0.0 to 2.4
|
1.4 Percentage of participants
Interval 0.0 to 3.1
|
2.0 Percentage of participants
Interval 0.1 to 3.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
2.0 Percentage of participants
Interval 0.1 to 3.9
|
1.8 Percentage of participants
Interval 0.1 to 3.6
|
2.6 Percentage of participants
Interval 0.4 to 4.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
1.6 Percentage of participants
Interval 0.0 to 3.4
|
2.9 Percentage of participants
Interval 0.6 to 5.2
|
1.5 Percentage of participants
Interval 0.0 to 3.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
2.1 Percentage of participants
Interval 0.1 to 4.1
|
1.0 Percentage of participants
Interval 0.0 to 2.3
|
2.0 Percentage of participants
Interval 0.1 to 3.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
1.5 Percentage of participants
Interval 0.0 to 3.2
|
1.9 Percentage of participants
Interval 0.1 to 3.7
|
1.6 Percentage of participants
Interval 0.0 to 3.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
3.2 Percentage of participants
Interval 0.7 to 5.6
|
0.5 Percentage of participants
Interval 0.0 to 1.5
|
2.1 Percentage of participants
Interval 0.1 to 4.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
2.7 Percentage of participants
Interval 0.4 to 5.0
|
2.4 Percentage of participants
Interval 0.3 to 4.5
|
2.0 Percentage of participants
Interval 0.1 to 4.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
3.0 Percentage of participants
Interval 0.6 to 5.4
|
3.8 Percentage of participants
Interval 1.2 to 6.3
|
2.1 Percentage of participants
Interval 0.1 to 4.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 16
|
34.5 Percentage of participants
Interval 29.1 to 39.8
|
38.0 Percentage of participants
Interval 32.5 to 43.6
|
34.0 Percentage of participants
Interval 28.6 to 39.5
|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 52
|
43.4 Percentage of participants
Interval 37.4 to 49.4
|
43.9 Percentage of participants
Interval 37.9 to 49.8
|
46.2 Percentage of participants
Interval 40.2 to 52.2
|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 96
|
53.5 Percentage of participants
Interval 46.9 to 60.1
|
44.3 Percentage of participants
Interval 37.9 to 50.7
|
43.8 Percentage of participants
Interval 37.2 to 50.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
37.2 Percentage of participants
Interval 31.1 to 43.3
|
39.5 Percentage of participants
Interval 33.3 to 45.7
|
37.3 Percentage of participants
Interval 31.0 to 43.7
|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
46.0 Percentage of participants
Interval 39.1 to 52.9
|
46.2 Percentage of participants
Interval 39.4 to 53.1
|
51.3 Percentage of participants
Interval 44.4 to 58.2
|
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
55.2 Percentage of participants
Interval 47.6 to 62.8
|
44.1 Percentage of participants
Interval 36.9 to 51.4
|
48.8 Percentage of participants
Interval 41.1 to 56.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 16
|
12.8 Percentage of participants
Interval 9.0 to 16.7
|
17.0 Percentage of participants
Interval 12.7 to 21.4
|
13.4 Percentage of participants
Interval 9.3 to 17.4
|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 52
|
16.3 Percentage of participants
Interval 11.7 to 20.8
|
19.2 Percentage of participants
Interval 14.4 to 24.0
|
19.2 Percentage of participants
Interval 14.4 to 24.0
|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 96
|
25.1 Percentage of participants
Interval 19.3 to 30.9
|
19.3 Percentage of participants
Interval 14.2 to 24.5
|
21.8 Percentage of participants
Interval 16.3 to 27.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
14.2 Percentage of participants
Interval 9.7 to 18.7
|
16.6 Percentage of participants
Interval 11.8 to 21.4
|
14.4 Percentage of participants
Interval 9.6 to 19.1
|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
18.9 Percentage of participants
Interval 13.4 to 24.4
|
19.0 Percentage of participants
Interval 13.6 to 24.3
|
21.6 Percentage of participants
Interval 15.9 to 27.4
|
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
27.9 Percentage of participants
Interval 21.0 to 34.8
|
19.2 Percentage of participants
Interval 13.4 to 25.0
|
25.7 Percentage of participants
Interval 19.0 to 32.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and each timepoint were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 16
|
3.6 Percentage of participants
Interval 1.4 to 5.8
|
8.3 Percentage of participants
Interval 5.2 to 11.5
|
3.4 Percentage of participants
Interval 1.2 to 5.5
|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 52
|
4.1 Percentage of participants
Interval 1.6 to 6.5
|
7.3 Percentage of participants
Interval 4.1 to 10.4
|
4.9 Percentage of participants
Interval 2.2 to 7.6
|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Week 96
|
7.7 Percentage of participants
Interval 4.1 to 11.2
|
7.3 Percentage of participants
Interval 4.0 to 10.6
|
5.3 Percentage of participants
Interval 2.3 to 8.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 52, and 96Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
3.6 Percentage of participants
Interval 1.1 to 6.0
|
6.5 Percentage of participants
Interval 3.3 to 9.7
|
3.3 Percentage of participants
Interval 0.9 to 5.8
|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
5.1 Percentage of participants
Interval 2.0 to 8.1
|
6.3 Percentage of participants
Interval 3.0 to 9.7
|
4.6 Percentage of participants
Interval 1.7 to 7.5
|
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
9.2 Percentage of participants
Interval 4.8 to 13.7
|
5.6 Percentage of participants
Interval 2.2 to 9.0
|
6.3 Percentage of participants
Interval 2.5 to 10.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=215 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=221 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=221 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
ITT Population
|
0.8 Percentage of participants
Interval 0.0 to 2.0
|
0.9 Percentage of participants
Interval 0.0 to 2.2
|
0.4 Percentage of participants
Interval 0.0 to 1.3
|
|
Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
0.6 Percentage of participants
Interval 0.0 to 1.8
|
1.2 Percentage of participants
Interval 0.0 to 2.8
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: ITT Population and Treatment-Naive Population. Only participants with non-missing, valid assessments at Baseline and Week 52 were included in the analysis.
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR. High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=230 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=250 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=236 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
ITT Population
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
0.0 Percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Week 52Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=308 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Once Every 4 Weeks
|
13.3 Percentage of participants
Interval 9.5 to 17.1
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Once Every 8 Weeks
|
15.6 Percentage of participants
Interval 11.5 to 19.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Once Every 12 Weeks
|
20.1 Percentage of participants
Interval 15.6 to 24.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Once Every 16 Weeks
|
51.0 Percentage of participants
Interval 45.4 to 56.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 52Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=245 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Once Every 12 Weeks
|
20.0 Percentage of participants
Interval 15.0 to 25.0
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Once Every 16 Weeks
|
54.3 Percentage of participants
Interval 48.0 to 60.5
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Once Every 4 Weeks
|
11.8 Percentage of participants
Interval 7.8 to 15.9
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Once Every 8 Weeks
|
13.9 Percentage of participants
Interval 9.5 to 18.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=287 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Once Every 4 Weeks
|
10.1 Percentage of participants
Interval 6.6 to 13.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Once Every 8 Weeks
|
11.8 Percentage of participants
Interval 8.1 to 15.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Once Every 12 Weeks
|
13.6 Percentage of participants
Interval 9.6 to 17.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Once Every 16 Weeks
|
64.5 Percentage of participants
Interval 58.9 to 70.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: Treatment-Naive Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization. Participants were grouped according to the treatment assigned at randomization. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=227 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Once Every 4 Weeks
|
9.3 Percentage of participants
Interval 5.5 to 13.0
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Once Every 8 Weeks
|
9.7 Percentage of participants
Interval 5.8 to 13.5
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Once Every 12 Weeks
|
12.8 Percentage of participants
Interval 8.4 to 17.1
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Once Every 16 Weeks
|
68.3 Percentage of participants
Interval 62.2 to 74.3
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of PTI (Week 12 or later) until Week 52Population: ITT Population and Treatment-Naive Population. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 52.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=308 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
ITT Population
|
64.3 Percentage of participants
Interval 58.9 to 69.6
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
66.9 Percentage of participants
Interval 61.0 to 72.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of PTI (Week 12 or later) until Week 96Population: ITT Population and Treatment-Naive Population. The number analyzed includes all participants in Arm B: Faricimab 6 mg PTI who had not discontinued the study prior to Week 96.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=287 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
ITT Population
|
63.1 Percentage of participants
Interval 57.5 to 68.7
|
—
|
—
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
65.6 Percentage of participants
Interval 59.4 to 71.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Week 56Population: ITT Population and Treatment-Naive Population
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
-195.8 microns
Interval -204.1 to -187.5
|
-187.6 microns
Interval -195.8 to -179.5
|
-170.1 microns
Interval -178.3 to -161.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
-195.0 microns
Interval -204.2 to -185.9
|
-189.4 microns
Interval -198.3 to -180.4
|
-175.1 microns
Interval -184.2 to -165.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 44
|
-181.7 microns
Interval -191.0 to -172.3
|
-185.9 microns
Interval -195.1 to -176.7
|
-172.3 microns
Interval -181.7 to -162.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 48
|
-195.6 microns
Interval -205.0 to -186.2
|
-184.9 microns
Interval -194.1 to -175.8
|
-162.7 microns
Interval -172.0 to -153.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 52
|
-188.6 microns
Interval -197.9 to -179.3
|
-186.1 microns
Interval -195.3 to -177.0
|
-176.6 microns
Interval -185.9 to -167.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 56
|
-199.0 microns
Interval -208.4 to -189.7
|
-188.5 microns
Interval -197.7 to -179.4
|
-168.2 microns
Interval -177.5 to -158.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 60
|
-194.1 microns
Interval -204.1 to -184.0
|
-186.1 microns
Interval -195.9 to -176.3
|
-179.0 microns
Interval -189.1 to -168.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 68
|
-196.2 microns
Interval -205.2 to -187.1
|
-190.3 microns
Interval -199.2 to -181.5
|
-181.4 microns
Interval -190.4 to -172.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 72
|
-202.8 microns
Interval -212.3 to -193.4
|
-191.9 microns
Interval -201.2 to -182.6
|
-172.5 microns
Interval -181.9 to -163.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 76
|
-198.8 microns
Interval -207.4 to -190.3
|
-191.3 microns
Interval -199.6 to -182.9
|
-185.4 microns
Interval -194.0 to -176.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 80
|
-204.0 microns
Interval -213.4 to -194.6
|
-189.7 microns
Interval -198.8 to -180.5
|
-176.7 microns
Interval -186.1 to -167.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 84
|
-198.2 microns
Interval -207.6 to -188.9
|
-197.9 microns
Interval -207.1 to -188.8
|
-185.5 microns
Interval -194.7 to -176.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 88
|
-201.5 microns
Interval -211.3 to -191.7
|
-194.9 microns
Interval -204.4 to -185.3
|
-177.1 microns
Interval -186.9 to -167.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 92
|
-200.5 microns
Interval -210.2 to -190.9
|
-195.4 microns
Interval -204.7 to -186.1
|
-184.0 microns
Interval -193.7 to -174.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 96
|
-206.3 microns
Interval -215.7 to -196.8
|
-199.0 microns
Interval -208.2 to -189.7
|
-180.0 microns
Interval -189.5 to -170.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 100
|
-201.1 microns
Interval -210.5 to -191.8
|
-196.9 microns
Interval -206.0 to -187.8
|
-192.8 microns
Interval -202.2 to -183.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 16
|
-162.2 microns
Interval -170.4 to -154.0
|
-167.1 microns
Interval -175.2 to -158.9
|
-151.4 microns
Interval -159.7 to -143.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 4
|
-106.1 microns
Interval -115.7 to -96.6
|
-113.9 microns
Interval -123.4 to -104.4
|
-107.3 microns
Interval -116.8 to -97.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 8
|
-132.0 microns
Interval -140.9 to -123.0
|
-139.6 microns
Interval -148.4 to -130.8
|
-129.6 microns
Interval -138.5 to -120.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 12
|
-146.0 microns
Interval -154.8 to -137.2
|
-155.0 microns
Interval -163.7 to -146.3
|
-143.1 microns
Interval -151.9 to -134.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 20
|
-166.8 microns
Interval -176.0 to -157.6
|
-157.2 microns
Interval -166.3 to -148.1
|
-154.6 microns
Interval -163.8 to -145.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 24
|
-179.9 microns
Interval -188.4 to -171.3
|
-181.4 microns
Interval -189.8 to -173.0
|
-146.6 microns
Interval -155.1 to -138.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 28
|
-164.8 microns
Interval -173.2 to -156.5
|
-184.0 microns
Interval -192.3 to -175.8
|
-165.0 microns
Interval -173.3 to -156.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 32
|
-181.9 microns
Interval -191.4 to -172.4
|
-169.4 microns
Interval -178.9 to -160.0
|
-154.8 microns
Interval -164.3 to -145.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 36
|
-170.9 microns
Interval -179.8 to -162.1
|
-189.2 microns
Interval -197.9 to -180.5
|
-168.6 microns
Interval -177.4 to -159.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 40
|
-191.6 microns
Interval -200.9 to -182.3
|
-183.8 microns
Interval -193.0 to -174.6
|
-160.0 microns
Interval -169.3 to -150.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Week 64
|
-197.2 microns
Interval -206.7 to -187.8
|
-189.8 microns
Interval -199.0 to -180.7
|
-172.1 microns
Interval -181.5 to -162.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: Treatment-Naive (TN) Population: all participants randomized in the study who had not received any intravitreal anti-VEGF agents in the study eye prior to randomization, grouped according to the treatment assigned at randomization. One participant in Arm B: Faricimab 6 mg PTI was excluded from the TN Population for the final analysis due to a late report of prior anti-VEGF treatment.
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=254 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=254 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=248 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 4
|
-106.3 microns
Interval -116.9 to -95.6
|
-112.9 microns
Interval -123.5 to -102.3
|
-106.3 microns
Interval -117.0 to -95.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 8
|
-131.8 microns
Interval -141.6 to -122.0
|
-140.6 microns
Interval -150.3 to -130.9
|
-130.4 microns
Interval -140.2 to -120.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 12
|
-148.8 microns
Interval -158.4 to -139.2
|
-156.6 microns
Interval -166.2 to -147.1
|
-145.3 microns
Interval -154.9 to -135.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 16
|
-163.0 microns
Interval -171.9 to -154.0
|
-168.8 microns
Interval -177.7 to -159.9
|
-157.0 microns
Interval -166.0 to -148.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 20
|
-170.5 microns
Interval -180.1 to -160.9
|
-162.3 microns
Interval -171.9 to -152.8
|
-160.6 microns
Interval -170.2 to -150.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 24
|
-182.4 microns
Interval -191.5 to -173.3
|
-182.9 microns
Interval -191.9 to -173.9
|
-154.6 microns
Interval -163.8 to -145.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 28
|
-166.8 microns
Interval -175.9 to -157.8
|
-183.9 microns
Interval -192.9 to -174.9
|
-174.2 microns
Interval -183.2 to -165.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 32
|
-183.7 microns
Interval -194.0 to -173.4
|
-168.0 microns
Interval -178.2 to -157.7
|
-161.0 microns
Interval -171.4 to -150.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 36
|
-173.8 microns
Interval -183.5 to -164.1
|
-191.5 microns
Interval -201.1 to -182.0
|
-175.6 microns
Interval -185.2 to -165.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 40
|
-191.6 microns
Interval -201.9 to -181.4
|
-186.9 microns
Interval -197.0 to -176.8
|
-165.6 microns
Interval -175.8 to -155.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 44
|
-181.4 microns
Interval -191.7 to -171.1
|
-188.9 microns
Interval -199.1 to -178.8
|
-177.6 microns
Interval -187.9 to -167.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 48
|
-194.5 microns
Interval -205.1 to -184.0
|
-186.8 microns
Interval -197.1 to -176.6
|
-165.8 microns
Interval -176.3 to -155.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 52
|
-188.7 microns
Interval -198.8 to -178.7
|
-186.6 microns
Interval -196.5 to -176.8
|
-181.3 microns
Interval -191.4 to -171.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 56
|
-196.7 microns
Interval -207.0 to -186.4
|
-189.9 microns
Interval -200.0 to -179.8
|
-174.0 microns
Interval -184.3 to -163.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 60
|
-194.3 microns
Interval -205.6 to -183.0
|
-185.2 microns
Interval -196.3 to -174.1
|
-184.1 microns
Interval -195.5 to -172.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 64
|
-196.5 microns
Interval -207.3 to -185.6
|
-191.2 microns
Interval -201.7 to -180.7
|
-175.6 microns
Interval -186.5 to -164.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 68
|
-194.6 microns
Interval -204.4 to -184.8
|
-192.7 microns
Interval -202.3 to -183.1
|
-186.3 microns
Interval -196.1 to -176.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 72
|
-200.9 microns
Interval -211.0 to -190.8
|
-193.4 microns
Interval -203.3 to -183.5
|
-178.0 microns
Interval -188.1 to -167.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 76
|
-200.2 microns
Interval -209.6 to -190.8
|
-192.0 microns
Interval -201.2 to -182.9
|
-190.2 microns
Interval -199.7 to -180.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 80
|
-202.6 microns
Interval -212.9 to -192.4
|
-190.0 microns
Interval -199.9 to -180.1
|
-182.6 microns
Interval -192.8 to -172.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 84
|
-199.3 microns
Interval -209.8 to -188.7
|
-196.0 microns
Interval -206.3 to -185.8
|
-189.5 microns
Interval -200.0 to -179.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 88
|
-200.3 microns
Interval -211.3 to -189.4
|
-195.6 microns
Interval -206.2 to -184.9
|
-181.9 microns
Interval -192.8 to -170.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 92
|
-199.3 microns
Interval -209.9 to -188.7
|
-196.0 microns
Interval -206.3 to -185.8
|
-187.2 microns
Interval -197.8 to -176.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 96
|
-204.5 microns
Interval -215.1 to -193.8
|
-200.8 microns
Interval -211.1 to -190.4
|
-182.9 microns
Interval -193.5 to -172.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Week 100
|
-200.9 microns
Interval -211.1 to -190.6
|
-198.7 microns
Interval -208.6 to -188.8
|
-193.5 microns
Interval -203.8 to -183.2
|
SECONDARY outcome
Timeframe: Average of Weeks 48, 52, and 56Population: ITT Population and Treatment-Naive Population. Only participants with at least one non-missing, valid assessment at Weeks 48, 52, or 56 were included in the analysis.
Absence of diabetic macular edema was defined as achieving a central subfield thickness (CST) of \<325 microns in the study eye. CST was defined as the distance between the internal limiting membrane and Bruch's membrane. For each participant, an average CST value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=268 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=294 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=279 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
ITT Population
|
85.5 Percentage of participants
Interval 81.3 to 89.7
|
81.5 Percentage of participants
Interval 77.1 to 85.9
|
73.2 Percentage of participants
Interval 68.0 to 78.3
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Treatment-Naive Population
|
86.0 Percentage of participants
Interval 81.3 to 90.7
|
83.2 Percentage of participants
Interval 78.4 to 88.0
|
77.0 Percentage of participants
Interval 71.3 to 82.6
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Absence of diabetic macular edema was defined as achieving a central subfield thickness of \<325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 4
|
38.2 Percentage of participants
Interval 32.8 to 43.6
|
43.5 Percentage of participants
Interval 38.0 to 49.0
|
38.1 Percentage of participants
Interval 32.8 to 43.5
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 8
|
53.3 Percentage of participants
Interval 47.7 to 58.9
|
57.3 Percentage of participants
Interval 51.9 to 62.7
|
47.9 Percentage of participants
Interval 42.4 to 53.5
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 12
|
61.8 Percentage of participants
Interval 56.5 to 67.2
|
64.8 Percentage of participants
Interval 59.4 to 70.1
|
56.4 Percentage of participants
Interval 50.8 to 62.0
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 16
|
69.2 Percentage of participants
Interval 64.0 to 74.4
|
69.1 Percentage of participants
Interval 63.9 to 74.2
|
62.3 Percentage of participants
Interval 56.8 to 67.8
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 20
|
73.8 Percentage of participants
Interval 68.9 to 78.8
|
67.2 Percentage of participants
Interval 62.0 to 72.4
|
67.4 Percentage of participants
Interval 62.1 to 72.7
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 24
|
77.7 Percentage of participants
Interval 73.0 to 82.4
|
77.9 Percentage of participants
Interval 73.2 to 82.5
|
62.4 Percentage of participants
Interval 57.0 to 67.9
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 28
|
72.1 Percentage of participants
Interval 67.0 to 77.3
|
81.2 Percentage of participants
Interval 76.8 to 85.6
|
71.2 Percentage of participants
Interval 66.1 to 76.4
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 32
|
80.2 Percentage of participants
Interval 75.6 to 84.9
|
72.1 Percentage of participants
Interval 67.0 to 77.3
|
67.0 Percentage of participants
Interval 61.5 to 72.4
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 36
|
73.8 Percentage of participants
Interval 68.7 to 79.0
|
83.8 Percentage of participants
Interval 79.5 to 88.1
|
74.6 Percentage of participants
Interval 69.6 to 79.7
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 40
|
86.1 Percentage of participants
Interval 82.1 to 90.2
|
81.5 Percentage of participants
Interval 77.0 to 86.0
|
72.1 Percentage of participants
Interval 66.9 to 77.3
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 44
|
81.5 Percentage of participants
Interval 76.9 to 86.0
|
80.3 Percentage of participants
Interval 75.7 to 84.9
|
76.6 Percentage of participants
Interval 71.6 to 81.6
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 48
|
87.5 Percentage of participants
Interval 83.4 to 91.6
|
82.7 Percentage of participants
Interval 78.4 to 87.1
|
71.0 Percentage of participants
Interval 65.7 to 76.4
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 52
|
83.7 Percentage of participants
Interval 79.3 to 88.2
|
82.1 Percentage of participants
Interval 77.6 to 86.6
|
76.4 Percentage of participants
Interval 71.5 to 81.4
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 56
|
89.5 Percentage of participants
Interval 85.9 to 93.2
|
85.4 Percentage of participants
Interval 81.4 to 89.5
|
72.2 Percentage of participants
Interval 66.9 to 77.6
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 60
|
85.4 Percentage of participants
Interval 81.1 to 89.6
|
86.1 Percentage of participants
Interval 82.0 to 90.1
|
78.8 Percentage of participants
Interval 73.9 to 83.8
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 64
|
87.6 Percentage of participants
Interval 83.5 to 91.7
|
82.8 Percentage of participants
Interval 78.5 to 87.2
|
73.8 Percentage of participants
Interval 68.5 to 79.0
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 68
|
85.0 Percentage of participants
Interval 80.6 to 89.3
|
83.2 Percentage of participants
Interval 78.8 to 87.6
|
78.2 Percentage of participants
Interval 73.1 to 83.2
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 72
|
88.9 Percentage of participants
Interval 85.1 to 92.8
|
82.4 Percentage of participants
Interval 77.8 to 86.9
|
74.6 Percentage of participants
Interval 69.2 to 80.0
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 76
|
88.4 Percentage of participants
Interval 84.6 to 92.3
|
82.2 Percentage of participants
Interval 77.7 to 86.7
|
79.3 Percentage of participants
Interval 74.3 to 84.4
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 80
|
90.0 Percentage of participants
Interval 86.3 to 93.8
|
83.4 Percentage of participants
Interval 78.9 to 87.8
|
76.6 Percentage of participants
Interval 71.4 to 81.9
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 84
|
88.2 Percentage of participants
Interval 84.2 to 92.2
|
85.8 Percentage of participants
Interval 81.6 to 90.0
|
80.3 Percentage of participants
Interval 75.4 to 85.2
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 88
|
89.5 Percentage of participants
Interval 85.9 to 93.2
|
85.0 Percentage of participants
Interval 80.7 to 89.2
|
78.8 Percentage of participants
Interval 73.8 to 83.9
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 92
|
88.4 Percentage of participants
Interval 84.5 to 92.4
|
84.6 Percentage of participants
Interval 80.3 to 88.9
|
80.3 Percentage of participants
Interval 75.3 to 85.3
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 96
|
92.7 Percentage of participants
Interval 89.5 to 95.8
|
88.1 Percentage of participants
Interval 84.2 to 92.0
|
80.0 Percentage of participants
Interval 74.9 to 85.0
|
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Week 100
|
90.6 Percentage of participants
Interval 87.0 to 94.2
|
85.5 Percentage of participants
Interval 81.3 to 89.7
|
84.2 Percentage of participants
Interval 79.6 to 88.8
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Retinal dryness was defined as achieving a central subfield thickness (ILM-BM) of \<280 microns. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 12
|
33.1 Percentage of participants
Interval 27.9 to 38.3
|
36.7 Percentage of participants
Interval 31.3 to 42.0
|
28.2 Percentage of participants
Interval 23.2 to 33.3
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 16
|
38.5 Percentage of participants
Interval 33.1 to 44.0
|
45.0 Percentage of participants
Interval 39.4 to 50.5
|
33.4 Percentage of participants
Interval 28.0 to 38.8
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 20
|
44.3 Percentage of participants
Interval 38.7 to 49.9
|
41.0 Percentage of participants
Interval 35.5 to 46.5
|
38.5 Percentage of participants
Interval 32.9 to 44.0
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 24
|
50.2 Percentage of participants
Interval 44.6 to 55.8
|
52.3 Percentage of participants
Interval 46.8 to 57.9
|
37.0 Percentage of participants
Interval 31.5 to 42.4
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 28
|
45.2 Percentage of participants
Interval 39.5 to 50.8
|
51.9 Percentage of participants
Interval 46.4 to 57.3
|
46.0 Percentage of participants
Interval 40.3 to 51.8
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 32
|
52.3 Percentage of participants
Interval 46.6 to 58.1
|
46.6 Percentage of participants
Interval 41.0 to 52.3
|
42.7 Percentage of participants
Interval 36.9 to 48.4
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 40
|
61.2 Percentage of participants
Interval 55.5 to 66.8
|
57.7 Percentage of participants
Interval 52.0 to 63.3
|
49.4 Percentage of participants
Interval 43.6 to 55.2
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 36
|
50.0 Percentage of participants
Interval 44.2 to 55.7
|
59.6 Percentage of participants
Interval 54.0 to 65.1
|
48.8 Percentage of participants
Interval 42.9 to 54.6
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 4
|
12.3 Percentage of participants
Interval 8.7 to 16.0
|
18.5 Percentage of participants
Interval 14.2 to 22.8
|
15.0 Percentage of participants
Interval 11.0 to 18.9
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 8
|
26.2 Percentage of participants
Interval 21.3 to 31.0
|
25.9 Percentage of participants
Interval 21.1 to 30.8
|
22.5 Percentage of participants
Interval 17.9 to 27.2
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 44
|
59.9 Percentage of participants
Interval 54.3 to 65.5
|
58.6 Percentage of participants
Interval 53.0 to 64.1
|
53.5 Percentage of participants
Interval 47.7 to 59.4
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 48
|
67.5 Percentage of participants
Interval 61.7 to 73.2
|
58.3 Percentage of participants
Interval 52.8 to 63.8
|
50.2 Percentage of participants
Interval 44.3 to 56.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 52
|
64.5 Percentage of participants
Interval 58.8 to 70.1
|
60.9 Percentage of participants
Interval 55.3 to 66.4
|
54.2 Percentage of participants
Interval 48.4 to 60.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 56
|
70.3 Percentage of participants
Interval 64.9 to 75.6
|
63.6 Percentage of participants
Interval 58.2 to 69.1
|
51.2 Percentage of participants
Interval 45.2 to 57.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 60
|
65.4 Percentage of participants
Interval 59.8 to 71.1
|
65.7 Percentage of participants
Interval 60.1 to 71.2
|
59.2 Percentage of participants
Interval 53.3 to 65.2
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 64
|
71.6 Percentage of participants
Interval 66.2 to 77.1
|
58.7 Percentage of participants
Interval 53.1 to 64.2
|
52.8 Percentage of participants
Interval 46.8 to 58.7
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 68
|
66.9 Percentage of participants
Interval 61.2 to 72.6
|
60.6 Percentage of participants
Interval 55.0 to 66.2
|
59.8 Percentage of participants
Interval 53.9 to 65.8
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 72
|
71.2 Percentage of participants
Interval 65.6 to 76.7
|
65.6 Percentage of participants
Interval 60.1 to 71.1
|
58.8 Percentage of participants
Interval 52.8 to 64.8
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 76
|
68.4 Percentage of participants
Interval 62.9 to 74.0
|
62.8 Percentage of participants
Interval 57.2 to 68.5
|
58.9 Percentage of participants
Interval 52.9 to 64.9
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 80
|
72.6 Percentage of participants
Interval 67.2 to 78.1
|
64.0 Percentage of participants
Interval 58.4 to 69.7
|
60.1 Percentage of participants
Interval 54.1 to 66.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 84
|
68.4 Percentage of participants
Interval 62.8 to 74.0
|
67.6 Percentage of participants
Interval 62.1 to 73.1
|
60.7 Percentage of participants
Interval 54.7 to 66.6
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 88
|
71.8 Percentage of participants
Interval 66.4 to 77.2
|
63.3 Percentage of participants
Interval 57.7 to 68.9
|
60.3 Percentage of participants
Interval 54.2 to 66.4
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 92
|
72.9 Percentage of participants
Interval 67.5 to 78.3
|
64.6 Percentage of participants
Interval 59.0 to 70.2
|
64.0 Percentage of participants
Interval 58.0 to 70.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 96
|
75.1 Percentage of participants
Interval 69.9 to 80.3
|
67.4 Percentage of participants
Interval 62.0 to 72.9
|
63.1 Percentage of participants
Interval 57.0 to 69.1
|
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Week 100
|
72.0 Percentage of participants
Interval 66.6 to 77.4
|
69.3 Percentage of participants
Interval 63.9 to 74.6
|
64.8 Percentage of participants
Interval 58.8 to 70.9
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 16
|
19.6 Percentage of participants
Interval 15.1 to 24.1
|
19.8 Percentage of participants
Interval 15.4 to 24.2
|
13.3 Percentage of participants
Interval 9.4 to 17.1
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 48
|
40.9 Percentage of participants
Interval 34.8 to 47.0
|
32.3 Percentage of participants
Interval 26.9 to 37.7
|
22.5 Percentage of participants
Interval 17.6 to 27.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 52
|
39.1 Percentage of participants
Interval 33.3 to 44.9
|
35.9 Percentage of participants
Interval 30.3 to 41.5
|
28.4 Percentage of participants
Interval 23.1 to 33.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 56
|
42.5 Percentage of participants
Interval 36.6 to 48.3
|
39.9 Percentage of participants
Interval 34.2 to 45.6
|
27.3 Percentage of participants
Interval 22.0 to 32.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 92
|
56.0 Percentage of participants
Interval 49.8 to 62.2
|
45.0 Percentage of participants
Interval 39.0 to 51.0
|
39.2 Percentage of participants
Interval 33.0 to 45.4
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 96
|
62.3 Percentage of participants
Interval 56.3 to 68.4
|
47.6 Percentage of participants
Interval 41.5 to 53.6
|
39.1 Percentage of participants
Interval 32.8 to 45.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Week 100
|
56.6 Percentage of participants
Interval 50.4 to 62.8
|
52.2 Percentage of participants
Interval 46.2 to 58.1
|
45.1 Percentage of participants
Interval 38.7 to 51.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 16
|
99.0 Percentage of participants
Interval 97.9 to 100.0
|
96.7 Percentage of participants
Interval 94.7 to 98.7
|
95.6 Percentage of participants
Interval 93.3 to 97.8
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 48
|
97.2 Percentage of participants
Interval 95.1 to 99.2
|
95.8 Percentage of participants
Interval 93.5 to 98.1
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 52
|
94.7 Percentage of participants
Interval 91.9 to 97.4
|
95.7 Percentage of participants
Interval 93.4 to 98.0
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 56
|
97.0 Percentage of participants
Interval 95.0 to 99.0
|
95.8 Percentage of participants
Interval 93.5 to 98.1
|
95.9 Percentage of participants
Interval 93.5 to 98.2
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 92
|
95.0 Percentage of participants
Interval 92.3 to 97.8
|
96.2 Percentage of participants
Interval 93.9 to 98.5
|
96.0 Percentage of participants
Interval 93.5 to 98.4
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 96
|
96.3 Percentage of participants
Interval 94.0 to 98.7
|
96.6 Percentage of participants
Interval 94.5 to 98.8
|
96.2 Percentage of participants
Interval 93.8 to 98.6
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 100
|
96.0 Percentage of participants
Interval 93.5 to 98.4
|
96.2 Percentage of participants
Interval 93.9 to 98.5
|
95.9 Percentage of participants
Interval 93.5 to 98.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At each timepoint, only participants with non-missing, valid assessments were included in the analysis.
Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 16
|
19.6 Percentage of participants
Interval 15.1 to 24.1
|
19.1 Percentage of participants
Interval 14.8 to 23.5
|
13.3 Percentage of participants
Interval 9.4 to 17.1
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 48
|
40.5 Percentage of participants
Interval 34.4 to 46.6
|
31.2 Percentage of participants
Interval 25.8 to 36.6
|
22.5 Percentage of participants
Interval 17.6 to 27.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 52
|
39.1 Percentage of participants
Interval 33.3 to 44.9
|
34.9 Percentage of participants
Interval 29.4 to 40.5
|
28.4 Percentage of participants
Interval 23.1 to 33.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 56
|
42.3 Percentage of participants
Interval 36.4 to 48.2
|
39.2 Percentage of participants
Interval 33.5 to 44.9
|
26.6 Percentage of participants
Interval 21.3 to 31.8
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 92
|
55.2 Percentage of participants
Interval 49.0 to 61.4
|
44.2 Percentage of participants
Interval 38.2 to 50.2
|
38.3 Percentage of participants
Interval 32.2 to 44.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 96
|
61.0 Percentage of participants
Interval 54.9 to 67.2
|
46.5 Percentage of participants
Interval 40.4 to 52.5
|
38.2 Percentage of participants
Interval 32.0 to 44.4
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Week 100
|
54.9 Percentage of participants
Interval 48.7 to 61.2
|
51.2 Percentage of participants
Interval 45.2 to 57.2
|
44.8 Percentage of participants
Interval 38.4 to 51.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24, 52, and 100Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
The NEI VFQ-25 captures a patient's perception of vision-related functioning and quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and one item on general health. The composite score ranges from 0 to 100, with higher scores, or a positive change from baseline, indicating better vision-related functioning. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% CI is a rounding of 95.04% CI.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=315 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
Week 24
|
5.7 score on a scale
Interval 4.6 to 6.9
|
6.5 score on a scale
Interval 5.4 to 7.7
|
7.0 score on a scale
Interval 5.9 to 8.1
|
|
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
Week 52
|
6.8 score on a scale
Interval 5.5 to 8.2
|
6.6 score on a scale
Interval 5.3 to 7.9
|
7.6 score on a scale
Interval 6.3 to 9.0
|
|
Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
Week 100
|
8.8 score on a scale
Interval 7.3 to 10.3
|
7.3 score on a scale
Interval 5.9 to 8.7
|
6.9 score on a scale
Interval 5.4 to 8.4
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 2 years)Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=314 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Adverse Event
Adverse Event (AE)
|
89.3 Percentage of participants
|
85.3 Percentage of participants
|
87.3 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
Serious AE (SAE)
|
30.6 Percentage of participants
|
25.7 Percentage of participants
|
31.8 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
AE Leading to Withdrawal from Study Treatment
|
2.2 Percentage of participants
|
2.8 Percentage of participants
|
1.6 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
AE of Special Interest (AESI)
|
7.6 Percentage of participants
|
7.2 Percentage of participants
|
6.4 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 2 years)Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=314 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Adverse Event (AE)
|
52.4 Percentage of participants
|
51.7 Percentage of participants
|
44.6 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Serious AE (SAE)
|
4.4 Percentage of participants
|
6.3 Percentage of participants
|
4.1 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AE Leading to Withdrawal from Treatment
|
0.3 Percentage of participants
|
1.9 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Treatment-related AE
|
3.2 Percentage of participants
|
4.4 Percentage of participants
|
4.8 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Treatment-related SAE
|
0.0 Percentage of participants
|
0.9 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AE of Special Interest (AESI)
|
4.4 Percentage of participants
|
6.3 Percentage of participants
|
3.8 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Drop in Visual Acuity (VA) Score ≥30 Letters
|
3.2 Percentage of participants
|
5.0 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Associated with Severe Intraocular Inflammation (IOI)
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss
|
0.9 Percentage of participants
|
1.3 Percentage of participants
|
1.0 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AE
|
50.5 Percentage of participants
|
43.3 Percentage of participants
|
44.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: SAE
|
3.5 Percentage of participants
|
1.9 Percentage of participants
|
3.5 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI
|
3.8 Percentage of participants
|
0.9 Percentage of participants
|
2.9 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI, Drop in VA Score ≥30 Letters
|
3.5 Percentage of participants
|
0.6 Percentage of participants
|
2.5 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI, Associated with Severe IOI
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 2 years)Population: The safety-evaluable population comprised all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=317 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=314 Participants
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
Adverse Event (AE)
|
69.4 Percentage of participants
|
68.3 Percentage of participants
|
73.6 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
Serious AE (SAE)
|
24.0 Percentage of participants
|
20.1 Percentage of participants
|
28.3 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
AE Leading to Withdrawal from Study Treatment
|
1.9 Percentage of participants
|
0.9 Percentage of participants
|
1.3 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
AE of Special Interest (AESI)
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100Population: This analysis only included participants in Arms A and B who received treatment with faricimab and with at least one plasma sample, provided sufficient dosing information (dose and dosing time) was available. The number of participants analyzed at a given timepoint includes those with an available plasma sample and dosing information at that timepoint.
Faricimab concentration in plasma was determined using a validated immunoassay method.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=315 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Plasma Concentration of Faricimab Over Time
Week 100
|
0.0058 micrograms per millilitre (μg/mL)
Standard Deviation 0.0106
|
0.0071 micrograms per millilitre (μg/mL)
Standard Deviation 0.0110
|
—
|
|
Plasma Concentration of Faricimab Over Time
Baseline
|
0.0001 micrograms per millilitre (μg/mL)
Standard Deviation 0.0020
|
0.0000 micrograms per millilitre (μg/mL)
Standard Deviation 0.0004
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 4
|
0.0192 micrograms per millilitre (μg/mL)
Standard Deviation 0.0163
|
0.0196 micrograms per millilitre (μg/mL)
Standard Deviation 0.0151
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 28
|
0.0030 micrograms per millilitre (μg/mL)
Standard Deviation 0.0050
|
0.0115 micrograms per millilitre (μg/mL)
Standard Deviation 0.0189
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 52
|
0.0042 micrograms per millilitre (μg/mL)
Standard Deviation 0.0078
|
0.0113 micrograms per millilitre (μg/mL)
Standard Deviation 0.0140
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 76
|
0.0060 micrograms per millilitre (μg/mL)
Standard Deviation 0.0093
|
0.0060 micrograms per millilitre (μg/mL)
Standard Deviation 0.0103
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 28, 52, 76, and 100Population: The analysis population consisted of all participants receiving faricimab with at least one determinant post-baseline ADA assessment.
Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.
Outcome measures
| Measure |
A: Faricimab 6 mg Q8W
n=313 Participants
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=318 Participants
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Total Treatment-Emergent ADA-Positive
|
7.0 Percentage of participants
|
8.2 Percentage of participants
|
—
|
|
Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Treatment-Induced ADA-Positive
|
7.0 Percentage of participants
|
8.2 Percentage of participants
|
—
|
|
Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Treatment-Boosted ADA-Positive
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
Adverse Events
A: Faricimab 6 mg Q8W
B: Faricimab 6 mg PTI
C: Aflibercept 2 mg Q8W
Serious adverse events
| Measure |
A: Faricimab 6 mg Q8W
n=317 participants at risk
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 participants at risk
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=314 participants at risk
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Angina unstable
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Atrial fibrillation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac arrest
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.94%
3/319 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/314 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
8/317 • Number of events 10 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/319 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
5/317 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.94%
3/319 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/314 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Right ventricular failure
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract
|
1.3%
4/317 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.2%
7/319 • Number of events 7 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.2%
7/314 • Number of events 7 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract subcapsular
|
0.32%
1/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Diabetic retinal oedema
|
2.2%
7/317 • Number of events 10 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Dry eye
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal tear
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Visual impairment
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous haemorrhage
|
1.3%
4/317 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Chest pain
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Inflammation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Necrosis
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Pyrexia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Soft tissue inflammation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Anal abscess
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.95%
3/317 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Cellulitis
|
0.95%
3/317 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.5%
8/314 • Number of events 8 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Cystitis
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Diabetic foot infection
|
1.3%
4/317 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Diabetic gangrene
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Endophthalmitis
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gangrene
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Influenza
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Osteomyelitis
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pneumonia
|
2.2%
7/317 • Number of events 7 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.9%
6/319 • Number of events 6 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.6%
5/314 • Number of events 6 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pyelonephritis
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Respiratory tract infection
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Sepsis
|
1.6%
5/317 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.6%
5/314 • Number of events 6 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Chemical burns of eye
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Blood glucose fluctuation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Intraocular pressure increased
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Diabetic endorgan damage
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 7 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.94%
3/319 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.32%
1/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.32%
1/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral infarction
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/314 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Syncope
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Depression
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
4/317 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/319 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/314 • Number of events 5 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Azotaemia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.3%
4/317 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
End stage renal disease
|
0.95%
3/317 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Renal cyst
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
2/317 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/319 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertension
|
0.63%
2/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypotension
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.63%
2/319 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.32%
1/317 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Endocrine disorders
Hyperplasia adrenal
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract nuclear
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Diabetic eye disease
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous detachment
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Anorectal varices
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Asthenia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Death
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Generalised oedema
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Hernia obstructive
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Peripheral swelling
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19
|
1.9%
6/317 • Number of events 6 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.2%
7/319 • Number of events 8 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.3%
4/314 • Number of events 4 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.64%
2/314 • Number of events 2 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Localised infection
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Nasopharyngitis
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Septic shock
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Biopsy bladder
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Lacunar infarction
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Monoplegia
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Surgical and medical procedures
Haemodialysis
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.32%
1/314 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Surgical and medical procedures
Hospitalisation
|
0.32%
1/317 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/319 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Haematoma
|
0.00%
0/317 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/319 • Number of events 1 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/314 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
Other adverse events
| Measure |
A: Faricimab 6 mg Q8W
n=317 participants at risk
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
B: Faricimab 6 mg PTI
n=319 participants at risk
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.
|
C: Aflibercept 2 mg Q8W
n=314 participants at risk
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
16.4%
52/317 • Number of events 77 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
18.2%
58/319 • Number of events 88 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
10.5%
33/314 • Number of events 48 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Conjunctival haemorrhage
|
11.4%
36/317 • Number of events 44 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
7.5%
24/319 • Number of events 29 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.0%
25/314 • Number of events 34 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Diabetic retinal oedema
|
9.1%
29/317 • Number of events 31 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
7.8%
25/319 • Number of events 30 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
7.3%
23/314 • Number of events 27 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous detachment
|
6.0%
19/317 • Number of events 26 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.6%
18/319 • Number of events 21 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.6%
27/314 • Number of events 30 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Nasopharyngitis
|
9.5%
30/317 • Number of events 35 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.5%
27/319 • Number of events 34 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
12.1%
38/314 • Number of events 43 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
14/317 • Number of events 20 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
4.7%
15/319 • Number of events 18 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.6%
27/314 • Number of events 35 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Headache
|
5.7%
18/317 • Number of events 36 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
3.4%
11/319 • Number of events 16 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.5%
8/314 • Number of events 10 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertension
|
6.3%
20/317 • Number of events 22 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.2%
26/319 • Number of events 29 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.1%
16/314 • Number of events 16 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Dry eye
|
6.0%
19/317 • Number of events 34 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
6.9%
22/319 • Number of events 39 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
3.5%
11/314 • Number of events 24 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous floaters
|
5.4%
17/317 • Number of events 22 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
3.8%
12/319 • Number of events 15 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.7%
18/314 • Number of events 21 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fall
|
5.7%
18/317 • Number of events 23 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.5%
8/319 • Number of events 8 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
4.5%
14/314 • Number of events 19 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Intraocular pressure increased
|
6.6%
21/317 • Number of events 34 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
4.4%
14/319 • Number of events 23 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
4.8%
15/314 • Number of events 27 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.4%
17/317 • Number of events 17 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.2%
7/319 • Number of events 7 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.96%
3/314 • Number of events 3 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
15/317 • Number of events 15 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.0%
16/319 • Number of events 17 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
3.2%
10/314 • Number of events 10 • From Baseline until Week 100
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER