Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (NCT NCT04740905)
NCT ID: NCT04740905
Last Updated: 2024-08-06
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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
553 participants
Primary outcome timeframe
From Baseline through Week 24
Results posted on
2024-08-06
Participant Flow
A total of 768 patients were screened; 9 of these patients were rescreened and randomized in the study. A total of 215 patients failed screening due to not meeting the inclusion criteria. A total of 553 patients with BRVO were randomized 1:1 into the study: 276 to the faricimab Q4W arm and 277 to the aflibercept Q4W arm.
Participant milestones
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|
|
Part 1 (Baseline up to Week 24)
STARTED
|
276
|
277
|
|
Part 1 (Baseline up to Week 24)
Received at Least One Dose of Study Drug
|
276
|
274
|
|
Part 1 (Baseline up to Week 24)
COMPLETED
|
271
|
274
|
|
Part 1 (Baseline up to Week 24)
NOT COMPLETED
|
5
|
3
|
|
Part 2 (Week 24 to Week 72)
STARTED
|
271
|
274
|
|
Part 2 (Week 24 to Week 72)
COMPLETED
|
245
|
244
|
|
Part 2 (Week 24 to Week 72)
NOT COMPLETED
|
26
|
30
|
Reasons for withdrawal
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|
|
Part 1 (Baseline up to Week 24)
Protocol Violation
|
0
|
3
|
|
Part 1 (Baseline up to Week 24)
Lost to Follow-up
|
2
|
0
|
|
Part 1 (Baseline up to Week 24)
Adverse Event
|
1
|
0
|
|
Part 1 (Baseline up to Week 24)
Withdrawal by Subject
|
1
|
0
|
|
Part 1 (Baseline up to Week 24)
Death
|
1
|
0
|
|
Part 2 (Week 24 to Week 72)
Withdrawal by Subject
|
13
|
12
|
|
Part 2 (Week 24 to Week 72)
Lost to Follow-up
|
7
|
6
|
|
Part 2 (Week 24 to Week 72)
Adverse Event
|
0
|
4
|
|
Part 2 (Week 24 to Week 72)
Physician Decision
|
0
|
4
|
|
Part 2 (Week 24 to Week 72)
Patient Missed Week 72 Visit Due to SAE
|
1
|
1
|
|
Part 2 (Week 24 to Week 72)
Death
|
1
|
2
|
|
Part 2 (Week 24 to Week 72)
Non-Compliance With Study Drug
|
2
|
1
|
|
Part 2 (Week 24 to Week 72)
Patient Could Not Return to Hospital Due to COVID-19 Epidemic
|
1
|
0
|
|
Part 2 (Week 24 to Week 72)
Patient Refused to Continue Study
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm A to receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants were randomly assigned to Arm B to receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Total
n=553 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
63.8 Years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
64.1 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
224 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
448 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
90 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
172 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Rest of the World
|
129 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Region of Enrollment
Asia
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Region of Enrollment
USA and Canada
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
Left Eye
|
140 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
Right Eye
|
136 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
286 Participants
n=5 Participants
|
|
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
|
57.50 ETDRS Letters
STANDARD_DEVIATION 13.04 • n=5 Participants
|
57.64 ETDRS Letters
STANDARD_DEVIATION 12.15 • n=7 Participants
|
57.57 ETDRS Letters
STANDARD_DEVIATION 12.59 • n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≤54 Letters (20/80 or Worse)
|
89 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≥55 Letters (20/80 or Better)
|
187 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline through Week 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
|
16.9 ETDRS Letters
Interval 15.7 to 18.1
|
17.5 ETDRS Letters
Interval 16.3 to 18.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
11.5 ETDRS Letters
Interval 10.5 to 12.5
|
12.4 ETDRS Letters
Interval 11.4 to 13.4
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
13.7 ETDRS Letters
Interval 12.6 to 14.7
|
15.1 ETDRS Letters
Interval 14.1 to 16.2
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
15.1 ETDRS Letters
Interval 14.0 to 16.2
|
15.9 ETDRS Letters
Interval 14.8 to 17.0
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
15.5 ETDRS Letters
Interval 14.4 to 16.6
|
16.5 ETDRS Letters
Interval 15.4 to 17.7
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
16.3 ETDRS Letters
Interval 15.2 to 17.4
|
17.3 ETDRS Letters
Interval 16.1 to 18.4
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
16.9 ETDRS Letters
Interval 15.7 to 18.1
|
17.5 ETDRS Letters
Interval 16.3 to 18.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24
|
56.1 Percentage of participants
Interval 50.4 to 61.9
|
60.4 Percentage of participants
Interval 54.7 to 66.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
34.3 Percentage of participants
Interval 28.9 to 39.8
|
36.9 Percentage of participants
Interval 31.5 to 42.3
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
41.2 Percentage of participants
Interval 35.6 to 46.9
|
46.7 Percentage of participants
Interval 41.0 to 52.3
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
51.0 Percentage of participants
Interval 45.3 to 56.7
|
52.1 Percentage of participants
Interval 46.3 to 57.8
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
53.6 Percentage of participants
Interval 47.8 to 59.3
|
56.4 Percentage of participants
Interval 50.8 to 62.1
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
56.1 Percentage of participants
Interval 50.3 to 61.8
|
58.9 Percentage of participants
Interval 53.3 to 64.6
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
56.1 Percentage of participants
Interval 50.4 to 61.9
|
60.4 Percentage of participants
Interval 54.7 to 66.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
57.5 Percentage of participants
Interval 51.8 to 63.3
|
59.2 Percentage of participants
Interval 53.6 to 64.9
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
69.1 Percentage of participants
Interval 63.8 to 74.5
|
69.0 Percentage of participants
Interval 63.6 to 74.4
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
75.0 Percentage of participants
Interval 69.9 to 80.1
|
74.8 Percentage of participants
Interval 69.7 to 79.8
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
72.1 Percentage of participants
Interval 66.9 to 77.3
|
76.6 Percentage of participants
Interval 71.6 to 81.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
75.3 Percentage of participants
Interval 70.3 to 80.4
|
79.1 Percentage of participants
Interval 74.3 to 83.9
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
77.5 Percentage of participants
Interval 72.6 to 82.4
|
77.3 Percentage of participants
Interval 72.4 to 82.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
75.7 Percentage of participants
Interval 70.7 to 80.7
|
79.1 Percentage of participants
Interval 74.4 to 83.9
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
84.0 Percentage of participants
Interval 79.7 to 88.3
|
88.1 Percentage of participants
Interval 84.3 to 91.9
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
87.0 Percentage of participants
Interval 83.1 to 90.9
|
87.0 Percentage of participants
Interval 83.1 to 91.0
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
85.9 Percentage of participants
Interval 81.8 to 89.9
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
88.4 Percentage of participants
Interval 84.6 to 92.2
|
90.3 Percentage of participants
Interval 86.8 to 93.7
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
90.9 Percentage of participants
Interval 87.6 to 94.3
|
89.6 Percentage of participants
Interval 86.0 to 93.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
90.2 Percentage of participants
Interval 86.8 to 93.6
|
93.2 Percentage of participants
Interval 90.3 to 96.1
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
92.7 Percentage of participants
Interval 89.7 to 95.8
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
94.2 Percentage of participants
Interval 91.5 to 97.0
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
93.8 Percentage of participants
Interval 91.1 to 96.6
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
96.0 Percentage of participants
Interval 93.8 to 98.3
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
95.3 Percentage of participants
Interval 92.9 to 97.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
98.5 Percentage of participants
Interval 97.1 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
97.8 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
8.7 Percentage of participants
Interval 5.5 to 11.9
|
8.6 Percentage of participants
Interval 5.5 to 11.8
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
14.1 Percentage of participants
Interval 10.3 to 18.0
|
15.5 Percentage of participants
Interval 11.5 to 19.5
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
15.6 Percentage of participants
Interval 11.7 to 19.6
|
20.2 Percentage of participants
Interval 15.7 to 24.6
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
17.4 Percentage of participants
Interval 13.3 to 21.6
|
22.0 Percentage of participants
Interval 17.4 to 26.5
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
20.7 Percentage of participants
Interval 16.2 to 25.2
|
23.8 Percentage of participants
Interval 19.0 to 28.5
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
22.9 Percentage of participants
Interval 18.2 to 27.6
|
23.8 Percentage of participants
Interval 19.1 to 28.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
55.6 Percentage of participants
Interval 50.6 to 60.5
|
62.3 Percentage of participants
Interval 57.3 to 67.3
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
63.9 Percentage of participants
Interval 59.3 to 68.6
|
70.3 Percentage of participants
Interval 65.7 to 74.9
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
69.0 Percentage of participants
Interval 64.4 to 73.6
|
69.2 Percentage of participants
Interval 64.4 to 74.0
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
72.2 Percentage of participants
Interval 67.7 to 76.8
|
72.1 Percentage of participants
Interval 67.5 to 76.8
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
73.3 Percentage of participants
Interval 69.1 to 77.6
|
76.1 Percentage of participants
Interval 71.7 to 80.5
|
—
|
—
|
|
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
73.7 Percentage of participants
Interval 69.3 to 78.1
|
76.5 Percentage of participants
Interval 71.9 to 81.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
3.6 Percentage of participants
Interval 2.0 to 5.3
|
1.5 Percentage of participants
Interval 0.1 to 2.9
|
—
|
—
|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
3.2 Percentage of participants
Interval 1.3 to 5.0
|
1.9 Percentage of participants
Interval 0.5 to 3.3
|
—
|
—
|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.5 Percentage of participants
Interval 0.2 to 2.8
|
—
|
—
|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (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 the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
-283.9 microns
Interval -290.1 to -277.8
|
-281.1 microns
Interval -287.2 to -274.9
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
-299.4 microns
Interval -305.2 to -293.7
|
-296.9 microns
Interval -302.6 to -291.2
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
-304.4 microns
Interval -309.7 to -299.1
|
-298.8 microns
Interval -304.1 to -293.5
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
-306.1 microns
Interval -311.5 to -300.8
|
-301.4 microns
Interval -306.7 to -296.1
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
-307.3 microns
Interval -312.5 to -302.1
|
-302.2 microns
Interval -307.4 to -297.0
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
-311.4 microns
Interval -316.4 to -306.4
|
-304.4 microns
Interval -309.3 to -299.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
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 percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
88.1 Percentage of participants
Interval 84.4 to 91.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
94.5 Percentage of participants
Interval 91.9 to 97.2
|
93.2 Percentage of participants
Interval 90.3 to 96.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
96.4 Percentage of participants
Interval 94.2 to 98.5
|
92.1 Percentage of participants
Interval 89.0 to 95.2
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
95.3 Percentage of participants
Interval 92.8 to 97.7
|
93.6 Percentage of participants
Interval 90.7 to 96.4
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
96.0 Percentage of participants
Interval 93.7 to 98.3
|
94.6 Percentage of participants
Interval 92.1 to 97.2
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
95.3 Percentage of participants
Interval 92.8 to 97.7
|
93.9 Percentage of participants
Interval 91.2 to 96.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
46.1 Percentage of participants
Interval 40.2 to 51.9
|
54.8 Percentage of participants
Interval 49.0 to 60.6
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
53.8 Percentage of participants
Interval 48.2 to 59.4
|
57.4 Percentage of participants
Interval 51.6 to 63.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
65.3 Percentage of participants
Interval 59.7 to 70.8
|
56.6 Percentage of participants
Interval 50.8 to 62.4
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
69.9 Percentage of participants
Interval 64.6 to 75.3
|
72.9 Percentage of participants
Interval 67.8 to 78.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
67.1 Percentage of participants
Interval 61.6 to 72.6
|
66.4 Percentage of participants
Interval 60.9 to 71.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
72.5 Percentage of participants
Interval 67.3 to 77.7
|
66.0 Percentage of participants
Interval 60.5 to 71.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
76.1 Percentage of participants
Interval 71.1 to 81.1
|
72.9 Percentage of participants
Interval 67.8 to 78.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
93.1 Percentage of participants
Interval 90.2 to 96.1
|
91.4 Percentage of participants
Interval 88.1 to 94.6
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
91.3 Percentage of participants
Interval 88.0 to 94.6
|
90.3 Percentage of participants
Interval 86.9 to 93.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
37.8 Percentage of participants
Interval 32.1 to 43.4
|
40.8 Percentage of participants
Interval 35.2 to 46.4
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
50.9 Percentage of participants
Interval 45.3 to 56.5
|
54.1 Percentage of participants
Interval 48.4 to 59.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
63.8 Percentage of participants
Interval 58.2 to 69.4
|
56.3 Percentage of participants
Interval 50.5 to 62.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
67.1 Percentage of participants
Interval 61.6 to 72.6
|
72.6 Percentage of participants
Interval 67.4 to 77.8
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
66.0 Percentage of participants
Interval 60.5 to 71.5
|
66.0 Percentage of participants
Interval 60.5 to 71.6
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
66.3 Percentage of participants
Interval 60.8 to 71.9
|
61.0 Percentage of participants
Interval 55.3 to 66.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing Baseline and Week 24 assessments were included for analysis.
The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=253 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=244 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
|
5.6 score on a scale
Interval 4.5 to 6.7
|
5.9 score on a scale
Interval 4.8 to 7.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
11.5 ETDRS Letters
Interval 10.5 to 12.5
|
12.4 ETDRS Letters
Interval 11.4 to 13.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
13.7 ETDRS Letters
Interval 12.6 to 14.7
|
15.1 ETDRS Letters
Interval 14.1 to 16.2
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
15.1 ETDRS Letters
Interval 14.0 to 16.1
|
15.9 ETDRS Letters
Interval 14.8 to 17.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
15.5 ETDRS Letters
Interval 14.4 to 16.6
|
16.5 ETDRS Letters
Interval 15.4 to 17.6
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
16.3 ETDRS Letters
Interval 15.1 to 17.4
|
17.2 ETDRS Letters
Interval 16.1 to 18.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
16.8 ETDRS Letters
Interval 15.6 to 17.9
|
17.5 ETDRS Letters
Interval 16.3 to 18.6
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
16.5 ETDRS Letters
Interval 15.3 to 17.6
|
17.3 ETDRS Letters
Interval 16.2 to 18.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
17.2 ETDRS Letters
Interval 16.0 to 18.4
|
17.5 ETDRS Letters
Interval 16.3 to 18.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
17.3 ETDRS Letters
Interval 16.1 to 18.4
|
18.0 ETDRS Letters
Interval 16.8 to 19.2
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
17.3 ETDRS Letters
Interval 16.1 to 18.4
|
17.7 ETDRS Letters
Interval 16.6 to 18.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
18.1 ETDRS Letters
Interval 16.8 to 19.3
|
17.7 ETDRS Letters
Interval 16.5 to 18.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
18.0 ETDRS Letters
Interval 16.8 to 19.3
|
18.2 ETDRS Letters
Interval 17.0 to 19.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
18.0 ETDRS Letters
Interval 16.7 to 19.3
|
18.4 ETDRS Letters
Interval 17.1 to 19.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
17.3 ETDRS Letters
Interval 16.0 to 18.6
|
18.1 ETDRS Letters
Interval 16.8 to 19.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
18.0 ETDRS Letters
Interval 16.7 to 19.3
|
18.6 ETDRS Letters
Interval 17.3 to 19.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
17.9 ETDRS Letters
Interval 16.6 to 19.2
|
18.6 ETDRS Letters
Interval 17.3 to 19.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
18.1 ETDRS Letters
Interval 16.8 to 19.4
|
18.8 ETDRS Letters
Interval 17.5 to 20.1
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
18.4 ETDRS Letters
Interval 17.1 to 19.7
|
18.8 ETDRS Letters
Interval 17.5 to 20.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
34.3 Percentage of participants
Interval 28.9 to 39.8
|
36.9 Percentage of participants
Interval 31.5 to 42.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
41.2 Percentage of participants
Interval 35.6 to 46.9
|
46.7 Percentage of participants
Interval 41.0 to 52.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
51.0 Percentage of participants
Interval 45.3 to 56.7
|
52.1 Percentage of participants
Interval 46.3 to 57.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
53.6 Percentage of participants
Interval 47.8 to 59.3
|
56.4 Percentage of participants
Interval 50.8 to 62.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
56.1 Percentage of participants
Interval 50.3 to 61.8
|
58.9 Percentage of participants
Interval 53.3 to 64.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
56.1 Percentage of participants
Interval 50.4 to 61.9
|
60.4 Percentage of participants
Interval 54.7 to 66.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
55.8 Percentage of participants
Interval 50.0 to 61.5
|
61.8 Percentage of participants
Interval 56.2 to 67.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
59.0 Percentage of participants
Interval 53.3 to 64.6
|
61.4 Percentage of participants
Interval 55.8 to 67.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
61.2 Percentage of participants
Interval 55.5 to 66.8
|
62.5 Percentage of participants
Interval 56.9 to 68.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
60.8 Percentage of participants
Interval 55.2 to 66.4
|
61.1 Percentage of participants
Interval 55.4 to 66.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
65.5 Percentage of participants
Interval 60.1 to 71.0
|
58.9 Percentage of participants
Interval 53.4 to 64.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
64.1 Percentage of participants
Interval 58.5 to 69.6
|
60.7 Percentage of participants
Interval 55.1 to 66.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
61.2 Percentage of participants
Interval 55.6 to 66.8
|
64.0 Percentage of participants
Interval 58.4 to 69.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
57.9 Percentage of participants
Interval 52.3 to 63.5
|
63.6 Percentage of participants
Interval 58.1 to 69.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
62.6 Percentage of participants
Interval 57.1 to 68.1
|
62.9 Percentage of participants
Interval 57.4 to 68.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
61.9 Percentage of participants
Interval 56.3 to 67.4
|
65.4 Percentage of participants
Interval 59.9 to 70.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
63.0 Percentage of participants
Interval 57.5 to 68.4
|
64.7 Percentage of participants
Interval 59.2 to 70.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
62.3 Percentage of participants
Interval 56.7 to 67.8
|
66.9 Percentage of participants
Interval 61.5 to 72.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
57.5 Percentage of participants
Interval 51.8 to 63.3
|
59.2 Percentage of participants
Interval 53.6 to 64.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
69.1 Percentage of participants
Interval 63.8 to 74.5
|
69.0 Percentage of participants
Interval 63.6 to 74.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
75.0 Percentage of participants
Interval 69.9 to 80.1
|
74.8 Percentage of participants
Interval 69.7 to 79.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
72.1 Percentage of participants
Interval 66.9 to 77.3
|
76.6 Percentage of participants
Interval 71.6 to 81.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
75.3 Percentage of participants
Interval 70.3 to 80.4
|
79.1 Percentage of participants
Interval 74.3 to 83.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
77.5 Percentage of participants
Interval 72.6 to 82.4
|
77.3 Percentage of participants
Interval 72.4 to 82.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
76.1 Percentage of participants
Interval 71.1 to 81.1
|
76.6 Percentage of participants
Interval 71.6 to 81.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
77.5 Percentage of participants
Interval 72.6 to 82.4
|
78.4 Percentage of participants
Interval 73.6 to 83.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
75.7 Percentage of participants
Interval 70.7 to 80.7
|
78.7 Percentage of participants
Interval 74.0 to 83.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
77.5 Percentage of participants
Interval 72.7 to 82.4
|
76.2 Percentage of participants
Interval 71.3 to 81.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
80.4 Percentage of participants
Interval 75.8 to 85.1
|
76.6 Percentage of participants
Interval 71.7 to 81.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
79.7 Percentage of participants
Interval 75.0 to 84.4
|
79.4 Percentage of participants
Interval 74.7 to 84.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
80.8 Percentage of participants
Interval 76.2 to 85.4
|
80.2 Percentage of participants
Interval 75.5 to 84.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
75.7 Percentage of participants
Interval 70.7 to 80.7
|
78.0 Percentage of participants
Interval 73.2 to 82.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
79.3 Percentage of participants
Interval 74.6 to 84.0
|
80.5 Percentage of participants
Interval 75.9 to 85.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
78.9 Percentage of participants
Interval 74.2 to 83.7
|
78.7 Percentage of participants
Interval 73.9 to 83.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
78.9 Percentage of participants
Interval 74.2 to 83.7
|
77.3 Percentage of participants
Interval 72.4 to 82.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
80.4 Percentage of participants
Interval 75.8 to 85.0
|
79.5 Percentage of participants
Interval 74.7 to 84.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
75.7 Percentage of participants
Interval 70.7 to 80.7
|
79.1 Percentage of participants
Interval 74.4 to 83.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
84.0 Percentage of participants
Interval 79.7 to 88.3
|
88.1 Percentage of participants
Interval 84.3 to 91.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
87.0 Percentage of participants
Interval 83.1 to 90.9
|
87.0 Percentage of participants
Interval 83.1 to 91.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
85.9 Percentage of participants
Interval 81.8 to 89.9
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
88.4 Percentage of participants
Interval 84.6 to 92.2
|
90.3 Percentage of participants
Interval 86.8 to 93.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
90.9 Percentage of participants
Interval 87.6 to 94.3
|
89.6 Percentage of participants
Interval 86.0 to 93.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
89.1 Percentage of participants
Interval 85.5 to 92.8
|
87.8 Percentage of participants
Interval 84.0 to 91.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
87.7 Percentage of participants
Interval 83.9 to 91.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
88.4 Percentage of participants
Interval 84.6 to 92.1
|
90.6 Percentage of participants
Interval 87.2 to 94.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
90.2 Percentage of participants
Interval 86.7 to 93.7
|
90.6 Percentage of participants
Interval 87.2 to 94.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
89.1 Percentage of participants
Interval 85.5 to 92.8
|
88.4 Percentage of participants
Interval 84.7 to 92.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
88.4 Percentage of participants
Interval 84.6 to 92.2
|
90.3 Percentage of participants
Interval 86.8 to 93.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
89.9 Percentage of participants
Interval 86.4 to 93.4
|
88.5 Percentage of participants
Interval 84.7 to 92.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
88.0 Percentage of participants
Interval 84.3 to 91.8
|
87.0 Percentage of participants
Interval 83.1 to 91.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
89.9 Percentage of participants
Interval 86.3 to 93.4
|
88.1 Percentage of participants
Interval 84.3 to 91.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
90.6 Percentage of participants
Interval 87.1 to 94.0
|
87.7 Percentage of participants
Interval 83.9 to 91.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
87.1 Percentage of participants
Interval 83.1 to 91.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
89.8 Percentage of participants
Interval 86.3 to 93.4
|
87.4 Percentage of participants
Interval 83.5 to 91.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
90.2 Percentage of participants
Interval 86.8 to 93.6
|
93.2 Percentage of participants
Interval 90.3 to 96.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
92.7 Percentage of participants
Interval 89.7 to 95.8
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
94.2 Percentage of participants
Interval 91.5 to 97.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
93.8 Percentage of participants
Interval 91.1 to 96.6
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
96.0 Percentage of participants
Interval 93.8 to 98.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
95.3 Percentage of participants
Interval 92.9 to 97.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
95.3 Percentage of participants
Interval 92.9 to 97.8
|
95.0 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
96.0 Percentage of participants
Interval 93.8 to 98.3
|
95.0 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
94.2 Percentage of participants
Interval 91.5 to 96.9
|
94.6 Percentage of participants
Interval 92.0 to 97.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
94.6 Percentage of participants
Interval 91.9 to 97.2
|
95.7 Percentage of participants
Interval 93.3 to 98.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
95.3 Percentage of participants
Interval 92.9 to 97.7
|
94.6 Percentage of participants
Interval 92.0 to 97.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
94.6 Percentage of participants
Interval 92.0 to 97.2
|
96.1 Percentage of participants
Interval 93.8 to 98.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
93.8 Percentage of participants
Interval 91.1 to 96.6
|
94.6 Percentage of participants
Interval 92.1 to 97.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
93.1 Percentage of participants
Interval 90.2 to 96.1
|
95.3 Percentage of participants
Interval 92.9 to 97.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
94.6 Percentage of participants
Interval 91.9 to 97.2
|
94.2 Percentage of participants
Interval 91.5 to 97.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
94.2 Percentage of participants
Interval 91.5 to 97.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
93.5 Percentage of participants
Interval 90.6 to 96.4
|
93.9 Percentage of participants
Interval 91.1 to 96.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
94.6 Percentage of participants
Interval 91.9 to 97.2
|
93.9 Percentage of participants
Interval 91.1 to 96.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
97.9 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
98.5 Percentage of participants
Interval 97.1 to 100.0
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
99.6 Percentage of participants
Interval 98.9 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
99.3 Percentage of participants
Interval 98.3 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
97.9 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
98.2 Percentage of participants
Interval 96.7 to 99.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
97.9 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.9 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.9 Percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
98.5 Percentage of participants
Interval 97.1 to 99.9
|
97.8 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
98.6 Percentage of participants
Interval 97.2 to 100.0
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
97.8 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
97.1 Percentage of participants
Interval 95.2 to 99.0
|
97.5 Percentage of participants
Interval 95.6 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
98.6 Percentage of participants
Interval 97.2 to 99.9
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
97.1 Percentage of participants
Interval 95.2 to 99.0
|
97.9 Percentage of participants
Interval 96.2 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
97.5 Percentage of participants
Interval 95.6 to 99.3
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
96.8 Percentage of participants
Interval 94.7 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, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
8.7 Percentage of participants
Interval 5.5 to 11.9
|
8.6 Percentage of participants
Interval 5.5 to 11.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
14.1 Percentage of participants
Interval 10.3 to 18.0
|
15.5 Percentage of participants
Interval 11.5 to 19.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
15.6 Percentage of participants
Interval 11.7 to 19.6
|
20.2 Percentage of participants
Interval 15.7 to 24.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
17.4 Percentage of participants
Interval 13.3 to 21.6
|
22.0 Percentage of participants
Interval 17.4 to 26.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
20.7 Percentage of participants
Interval 16.2 to 25.2
|
23.8 Percentage of participants
Interval 19.0 to 28.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
22.9 Percentage of participants
Interval 18.2 to 27.6
|
23.8 Percentage of participants
Interval 19.1 to 28.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
24.0 Percentage of participants
Interval 19.2 to 28.8
|
25.6 Percentage of participants
Interval 20.7 to 30.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
25.1 Percentage of participants
Interval 20.3 to 29.8
|
23.4 Percentage of participants
Interval 18.8 to 28.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
25.1 Percentage of participants
Interval 20.2 to 29.9
|
25.2 Percentage of participants
Interval 20.4 to 30.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
26.9 Percentage of participants
Interval 22.0 to 31.8
|
22.0 Percentage of participants
Interval 17.4 to 26.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
26.8 Percentage of participants
Interval 21.8 to 31.8
|
24.8 Percentage of participants
Interval 20.0 to 29.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
29.0 Percentage of participants
Interval 24.0 to 34.1
|
25.2 Percentage of participants
Interval 20.3 to 30.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
26.8 Percentage of participants
Interval 21.9 to 31.7
|
25.6 Percentage of participants
Interval 20.7 to 30.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
26.1 Percentage of participants
Interval 21.2 to 31.0
|
22.0 Percentage of participants
Interval 17.3 to 26.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
27.6 Percentage of participants
Interval 22.6 to 32.6
|
25.6 Percentage of participants
Interval 20.8 to 30.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
30.1 Percentage of participants
Interval 25.0 to 35.3
|
24.5 Percentage of participants
Interval 19.7 to 29.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
29.4 Percentage of participants
Interval 24.2 to 34.6
|
25.9 Percentage of participants
Interval 21.0 to 30.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
29.4 Percentage of participants
Interval 24.3 to 34.5
|
24.8 Percentage of participants
Interval 20.0 to 29.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
55.6 Percentage of participants
Interval 50.6 to 60.5
|
62.3 Percentage of participants
Interval 57.3 to 67.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
63.9 Percentage of participants
Interval 59.3 to 68.6
|
70.3 Percentage of participants
Interval 65.7 to 74.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
69.0 Percentage of participants
Interval 64.4 to 73.6
|
69.2 Percentage of participants
Interval 64.4 to 74.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
72.2 Percentage of participants
Interval 67.7 to 76.8
|
72.1 Percentage of participants
Interval 67.5 to 76.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
73.3 Percentage of participants
Interval 69.1 to 77.6
|
76.1 Percentage of participants
Interval 71.7 to 80.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
73.7 Percentage of participants
Interval 69.3 to 78.1
|
76.5 Percentage of participants
Interval 71.9 to 81.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
73.3 Percentage of participants
Interval 68.7 to 77.9
|
75.4 Percentage of participants
Interval 70.7 to 80.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
76.9 Percentage of participants
Interval 72.6 to 81.2
|
75.4 Percentage of participants
Interval 70.7 to 80.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
76.2 Percentage of participants
Interval 71.8 to 80.6
|
77.9 Percentage of participants
Interval 73.3 to 82.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
75.5 Percentage of participants
Interval 71.0 to 79.9
|
76.8 Percentage of participants
Interval 72.3 to 81.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
76.9 Percentage of participants
Interval 72.4 to 81.4
|
76.1 Percentage of participants
Interval 71.4 to 80.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
77.2 Percentage of participants
Interval 72.7 to 81.8
|
79.3 Percentage of participants
Interval 75.0 to 83.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
78.7 Percentage of participants
Interval 74.3 to 83.1
|
80.4 Percentage of participants
Interval 76.1 to 84.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
76.2 Percentage of participants
Interval 71.5 to 80.9
|
79.0 Percentage of participants
Interval 74.5 to 83.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
80.2 Percentage of participants
Interval 75.8 to 84.5
|
79.0 Percentage of participants
Interval 74.5 to 83.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
77.6 Percentage of participants
Interval 73.0 to 82.2
|
81.1 Percentage of participants
Interval 76.8 to 85.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
77.6 Percentage of participants
Interval 73.0 to 82.2
|
80.4 Percentage of participants
Interval 76.0 to 84.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
78.0 Percentage of participants
Interval 73.5 to 82.4
|
79.0 Percentage of participants
Interval 74.4 to 83.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
3.6 Percentage of participants
Interval 2.0 to 5.3
|
1.5 Percentage of participants
Interval 0.1 to 2.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
3.2 Percentage of participants
Interval 1.3 to 5.0
|
1.9 Percentage of participants
Interval 0.5 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.5 Percentage of participants
Interval 0.2 to 2.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
2.3 Percentage of participants
Interval 0.8 to 3.8
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
2.0 Percentage of participants
Interval 0.6 to 3.5
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
2.4 Percentage of participants
Interval 0.8 to 4.0
|
1.9 Percentage of participants
Interval 0.4 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
1.9 Percentage of participants
Interval 0.5 to 3.4
|
1.5 Percentage of participants
Interval 0.2 to 2.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
2.3 Percentage of participants
Interval 0.8 to 3.7
|
1.5 Percentage of participants
Interval 0.2 to 2.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
2.7 Percentage of participants
Interval 1.0 to 4.4
|
1.5 Percentage of participants
Interval 0.2 to 2.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
2.4 Percentage of participants
Interval 0.8 to 4.0
|
2.2 Percentage of participants
Interval 0.6 to 3.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
3.1 Percentage of participants
Interval 1.3 to 4.9
|
2.6 Percentage of participants
Interval 0.9 to 4.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
2.7 Percentage of participants
Interval 1.0 to 4.4
|
2.6 Percentage of participants
Interval 0.9 to 4.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
2.1 Percentage of participants
Interval 0.6 to 3.6
|
2.6 Percentage of participants
Interval 0.9 to 4.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
3.1 Percentage of participants
Interval 1.3 to 4.9
|
2.2 Percentage of participants
Interval 0.6 to 3.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
2.1 Percentage of participants
Interval 0.6 to 3.6
|
1.8 Percentage of participants
Interval 0.3 to 3.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
2.1 Percentage of participants
Interval 0.6 to 3.6
|
2.2 Percentage of participants
Interval 0.5 to 3.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 48, and 72Population: Intent-to-Treat (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 vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the MMRM analysis, the model adjusted for the treatment group, visit, visit-by-treatment group interaction, baseline NEI VFQ-25 Composite Score continuous), baseline BCVA score (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were implicitly imputed. Invalid BCVA values were excluded. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Week 72
|
6.0 score on a scale
Interval 4.8 to 7.3
|
7.8 score on a scale
Interval 6.6 to 9.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Week 24
|
5.6 score on a scale
Interval 4.5 to 6.6
|
5.9 score on a scale
Interval 4.9 to 7.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Week 48
|
6.4 score on a scale
Interval 5.3 to 7.5
|
6.3 score on a scale
Interval 5.2 to 7.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
-287.3 microns
Interval -293.5 to -281.1
|
-284.3 microns
Interval -290.4 to -278.2
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
-302.9 microns
Interval -308.7 to -297.2
|
-300.2 microns
Interval -306.0 to -294.5
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
-307.8 microns
Interval -313.1 to -302.6
|
-301.9 microns
Interval -307.1 to -296.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
-309.3 microns
Interval -314.6 to -304.0
|
-304.5 microns
Interval -309.8 to -299.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
-310.6 microns
Interval -315.5 to -305.6
|
-304.2 microns
Interval -309.1 to -299.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
-314.5 microns
Interval -319.5 to -309.6
|
-307.6 microns
Interval -312.5 to -302.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
-294.0 microns
Interval -302.2 to -285.8
|
-285.1 microns
Interval -293.3 to -276.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
-308.3 microns
Interval -314.6 to -302.0
|
-303.2 microns
Interval -309.4 to -297.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
-304.1 microns
Interval -310.6 to -297.6
|
-298.8 microns
Interval -305.2 to -292.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
-296.7 microns
Interval -304.4 to -288.9
|
-285.8 microns
Interval -293.7 to -278.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
-309.2 microns
Interval -315.9 to -302.5
|
-301.6 microns
Interval -308.3 to -294.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
-309.4 microns
Interval -315.3 to -303.5
|
-302.8 microns
Interval -308.7 to -296.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
-302.2 microns
Interval -308.6 to -295.7
|
-302.4 microns
Interval -308.8 to -296.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
-294.0 microns
Interval -302.6 to -285.5
|
-288.0 microns
Interval -296.6 to -279.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
-309.5 microns
Interval -315.1 to -303.9
|
-306.2 microns
Interval -311.9 to -300.6
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
-311.1 microns
Interval -316.3 to -305.9
|
-305.9 microns
Interval -311.1 to -300.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
-311.2 microns
Interval -316.3 to -306.1
|
-307.9 microns
Interval -313.0 to -302.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
-310.5 microns
Interval -315.7 to -305.4
|
-307.2 microns
Interval -312.3 to -302.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
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 percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
88.1 Percentage of participants
Interval 84.4 to 91.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
94.5 Percentage of participants
Interval 91.9 to 97.2
|
93.2 Percentage of participants
Interval 90.3 to 96.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
96.4 Percentage of participants
Interval 94.2 to 98.5
|
92.1 Percentage of participants
Interval 89.0 to 95.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
95.3 Percentage of participants
Interval 92.8 to 97.7
|
93.6 Percentage of participants
Interval 90.7 to 96.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
96.0 Percentage of participants
Interval 93.7 to 98.3
|
94.6 Percentage of participants
Interval 92.1 to 97.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
95.6 Percentage of participants
Interval 93.3 to 98.0
|
94.3 Percentage of participants
Interval 91.6 to 96.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
89.1 Percentage of participants
Interval 85.5 to 92.8
|
86.0 Percentage of participants
Interval 82.0 to 90.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
94.6 Percentage of participants
Interval 91.9 to 97.2
|
92.5 Percentage of participants
Interval 89.4 to 95.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
93.8 Percentage of participants
Interval 91.1 to 96.5
|
90.7 Percentage of participants
Interval 87.3 to 94.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
89.5 Percentage of participants
Interval 85.9 to 93.0
|
84.2 Percentage of participants
Interval 79.9 to 88.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
96.0 Percentage of participants
Interval 93.7 to 98.3
|
92.1 Percentage of participants
Interval 88.9 to 95.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
91.4 Percentage of participants
Interval 88.1 to 94.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
92.4 Percentage of participants
Interval 89.3 to 95.5
|
91.4 Percentage of participants
Interval 88.2 to 94.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
86.3 Percentage of participants
Interval 82.3 to 90.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
94.2 Percentage of participants
Interval 91.5 to 96.9
|
93.9 Percentage of participants
Interval 91.1 to 96.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
93.9 Percentage of participants
Interval 91.1 to 96.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
92.4 Percentage of participants
Interval 89.4 to 95.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
94.2 Percentage of participants
Interval 91.5 to 96.9
|
94.2 Percentage of participants
Interval 91.5 to 97.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
46.1 Percentage of participants
Interval 40.2 to 51.9
|
54.8 Percentage of participants
Interval 49.0 to 60.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
53.8 Percentage of participants
Interval 48.2 to 59.4
|
57.4 Percentage of participants
Interval 51.6 to 63.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
65.3 Percentage of participants
Interval 59.7 to 70.8
|
56.6 Percentage of participants
Interval 50.8 to 62.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
69.9 Percentage of participants
Interval 64.6 to 75.3
|
72.9 Percentage of participants
Interval 67.8 to 78.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
67.1 Percentage of participants
Interval 61.6 to 72.6
|
66.4 Percentage of participants
Interval 60.9 to 71.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
73.9 Percentage of participants
Interval 68.9 to 79.0
|
69.3 Percentage of participants
Interval 63.9 to 74.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
54.4 Percentage of participants
Interval 48.7 to 60.2
|
47.6 Percentage of participants
Interval 41.8 to 53.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
68.1 Percentage of participants
Interval 62.6 to 73.6
|
65.0 Percentage of participants
Interval 59.4 to 70.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
60.9 Percentage of participants
Interval 55.1 to 66.6
|
56.0 Percentage of participants
Interval 50.2 to 61.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
50.8 Percentage of participants
Interval 45.0 to 56.6
|
48.1 Percentage of participants
Interval 42.3 to 53.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
70.3 Percentage of participants
Interval 64.9 to 75.6
|
63.9 Percentage of participants
Interval 58.3 to 69.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
76.1 Percentage of participants
Interval 71.1 to 81.1
|
67.9 Percentage of participants
Interval 62.5 to 73.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
55.8 Percentage of participants
Interval 50.0 to 61.7
|
56.7 Percentage of participants
Interval 50.9 to 62.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
58.4 Percentage of participants
Interval 52.6 to 64.1
|
58.9 Percentage of participants
Interval 53.2 to 64.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
75.0 Percentage of participants
Interval 69.9 to 80.1
|
72.6 Percentage of participants
Interval 67.4 to 77.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
75.8 Percentage of participants
Interval 70.9 to 80.7
|
69.7 Percentage of participants
Interval 64.3 to 75.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
69.9 Percentage of participants
Interval 64.5 to 75.3
|
68.6 Percentage of participants
Interval 63.2 to 74.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
72.8 Percentage of participants
Interval 67.6 to 78.0
|
72.9 Percentage of participants
Interval 67.7 to 78.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
76.1 Percentage of participants
Interval 71.1 to 81.1
|
72.9 Percentage of participants
Interval 67.8 to 78.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
93.1 Percentage of participants
Interval 90.2 to 96.1
|
91.4 Percentage of participants
Interval 88.1 to 94.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.8 Percentage of participants
Interval 96.1 to 99.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
91.3 Percentage of participants
Interval 88.0 to 94.6
|
90.3 Percentage of participants
Interval 86.9 to 93.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
93.5 Percentage of participants
Interval 90.7 to 96.4
|
91.0 Percentage of participants
Interval 87.6 to 94.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
96.0 Percentage of participants
Interval 93.7 to 98.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
95.7 Percentage of participants
Interval 93.3 to 98.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
95.7 Percentage of participants
Interval 93.3 to 98.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
97.1 Percentage of participants
Interval 95.1 to 99.1
|
94.6 Percentage of participants
Interval 91.9 to 97.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
98.2 Percentage of participants
Interval 96.6 to 99.8
|
97.1 Percentage of participants
Interval 95.2 to 99.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
95.3 Percentage of participants
Interval 92.8 to 97.8
|
95.0 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
95.7 Percentage of participants
Interval 93.3 to 98.1
|
96.0 Percentage of participants
Interval 93.8 to 98.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
98.2 Percentage of participants
Interval 96.7 to 99.7
|
96.8 Percentage of participants
Interval 94.7 to 98.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
97.5 Percentage of participants
Interval 95.6 to 99.3
|
97.5 Percentage of participants
Interval 95.7 to 99.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
96.4 Percentage of participants
Interval 94.2 to 98.6
|
94.9 Percentage of participants
Interval 92.4 to 97.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization.
Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
37.8 Percentage of participants
Interval 32.1 to 43.4
|
40.8 Percentage of participants
Interval 35.2 to 46.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
50.9 Percentage of participants
Interval 45.3 to 56.5
|
54.1 Percentage of participants
Interval 48.4 to 59.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
63.8 Percentage of participants
Interval 58.2 to 69.4
|
56.3 Percentage of participants
Interval 50.5 to 62.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
67.1 Percentage of participants
Interval 61.6 to 72.6
|
72.6 Percentage of participants
Interval 67.4 to 77.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
66.0 Percentage of participants
Interval 60.5 to 71.5
|
66.0 Percentage of participants
Interval 60.5 to 71.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
67.4 Percentage of participants
Interval 61.9 to 72.9
|
64.3 Percentage of participants
Interval 58.6 to 69.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
53.0 Percentage of participants
Interval 47.2 to 58.7
|
46.9 Percentage of participants
Interval 41.1 to 52.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
67.4 Percentage of participants
Interval 61.9 to 72.9
|
64.6 Percentage of participants
Interval 59.0 to 70.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
60.5 Percentage of participants
Interval 54.8 to 66.3
|
54.2 Percentage of participants
Interval 48.4 to 59.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
50.4 Percentage of participants
Interval 44.6 to 56.2
|
47.3 Percentage of participants
Interval 41.5 to 53.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
69.6 Percentage of participants
Interval 64.2 to 74.9
|
63.6 Percentage of participants
Interval 57.9 to 69.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
74.7 Percentage of participants
Interval 69.6 to 79.8
|
65.4 Percentage of participants
Interval 59.8 to 70.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
55.5 Percentage of participants
Interval 49.6 to 61.3
|
55.6 Percentage of participants
Interval 49.8 to 61.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
58.0 Percentage of participants
Interval 52.2 to 63.8
|
57.8 Percentage of participants
Interval 52.0 to 63.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
73.9 Percentage of participants
Interval 68.8 to 79.1
|
70.4 Percentage of participants
Interval 65.1 to 75.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
75.4 Percentage of participants
Interval 70.5 to 80.4
|
69.3 Percentage of participants
Interval 64.0 to 74.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
68.9 Percentage of participants
Interval 63.4 to 74.3
|
68.3 Percentage of participants
Interval 62.8 to 73.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
70.7 Percentage of participants
Interval 65.3 to 76.0
|
71.1 Percentage of participants
Interval 65.8 to 76.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (ITT) Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with evaluable Week 24 BCVA 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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=254 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=247 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
-0.3 ETDRS Letters
Interval -0.8 to 0.3
|
-0.1 ETDRS Letters
Interval -0.6 to 0.5
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
0.5 ETDRS Letters
Interval -0.1 to 1.0
|
0.0 ETDRS Letters
Interval -0.6 to 0.5
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
0.5 ETDRS Letters
Interval -0.2 to 1.2
|
0.6 ETDRS Letters
Interval -0.1 to 1.2
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
0.3 ETDRS Letters
Interval -0.4 to 1.1
|
0.4 ETDRS Letters
Interval -0.3 to 1.2
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
1.1 ETDRS Letters
Interval 0.3 to 1.9
|
0.3 ETDRS Letters
Interval -0.5 to 1.1
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
1.1 ETDRS Letters
Interval 0.3 to 2.0
|
0.7 ETDRS Letters
Interval -0.1 to 1.6
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
1.1 ETDRS Letters
Interval 0.2 to 2.0
|
0.9 ETDRS Letters
Interval 0.0 to 1.8
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
0.4 ETDRS Letters
Interval -0.5 to 1.4
|
0.6 ETDRS Letters
Interval -0.3 to 1.6
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
1.0 ETDRS Letters
Interval 0.1 to 2.0
|
1.1 ETDRS Letters
Interval 0.1 to 2.0
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
0.9 ETDRS Letters
Interval 0.0 to 1.9
|
1.2 ETDRS Letters
Interval 0.2 to 2.2
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
1.2 ETDRS Letters
Interval 0.2 to 2.1
|
1.3 ETDRS Letters
Interval 0.4 to 2.2
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
1.5 ETDRS Letters
Interval 0.5 to 2.5
|
1.3 ETDRS Letters
Interval 0.3 to 2.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
85.5 Percentage of participants
Interval 81.4 to 89.6
|
84.1 Percentage of participants
Interval 79.8 to 88.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
89.1 Percentage of participants
Interval 85.5 to 92.7
|
87.7 Percentage of participants
Interval 83.9 to 91.5
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
88.4 Percentage of participants
Interval 84.7 to 92.2
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
89.5 Percentage of participants
Interval 85.9 to 93.0
|
88.0 Percentage of participants
Interval 84.2 to 91.8
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
89.9 Percentage of participants
Interval 86.3 to 93.4
|
86.3 Percentage of participants
Interval 82.2 to 90.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
86.6 Percentage of participants
Interval 82.6 to 90.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
89.9 Percentage of participants
Interval 86.3 to 93.4
|
87.7 Percentage of participants
Interval 83.9 to 91.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
88.0 Percentage of participants
Interval 84.3 to 91.8
|
86.6 Percentage of participants
Interval 82.6 to 90.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
87.0 Percentage of participants
Interval 83.0 to 90.9
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
89.5 Percentage of participants
Interval 85.9 to 93.1
|
86.6 Percentage of participants
Interval 82.6 to 90.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
88.4 Percentage of participants
Interval 84.7 to 92.1
|
87.0 Percentage of participants
Interval 83.0 to 90.9
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
88.4 Percentage of participants
Interval 84.7 to 92.1
|
87.0 Percentage of participants
Interval 83.0 to 90.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
84.8 Percentage of participants
Interval 80.6 to 89.0
|
82.3 Percentage of participants
Interval 77.8 to 86.7
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
85.9 Percentage of participants
Interval 81.8 to 89.9
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
87.3 Percentage of participants
Interval 83.4 to 91.2
|
87.0 Percentage of participants
Interval 83.0 to 90.9
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
87.7 Percentage of participants
Interval 83.8 to 91.5
|
86.3 Percentage of participants
Interval 82.2 to 90.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
88.8 Percentage of participants
Interval 85.1 to 92.5
|
85.5 Percentage of participants
Interval 81.4 to 89.7
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
88.4 Percentage of participants
Interval 84.7 to 92.2
|
85.2 Percentage of participants
Interval 81.0 to 89.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
88.4 Percentage of participants
Interval 84.7 to 92.2
|
85.2 Percentage of participants
Interval 81.0 to 89.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
86.2 Percentage of participants
Interval 82.2 to 90.2
|
83.4 Percentage of participants
Interval 79.0 to 87.7
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
86.9 Percentage of participants
Interval 83.0 to 90.9
|
83.4 Percentage of participants
Interval 79.0 to 87.7
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
86.9 Percentage of participants
Interval 83.0 to 90.9
|
85.2 Percentage of participants
Interval 81.0 to 89.4
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
86.6 Percentage of participants
Interval 82.6 to 90.6
|
85.5 Percentage of participants
Interval 81.4 to 89.7
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
86.6 Percentage of participants
Interval 82.6 to 90.6
|
85.5 Percentage of participants
Interval 81.4 to 89.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
74.6 Percentage of participants
Interval 69.5 to 79.7
|
73.6 Percentage of participants
Interval 68.5 to 78.8
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
80.0 Percentage of participants
Interval 75.4 to 84.7
|
77.2 Percentage of participants
Interval 72.3 to 82.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
79.7 Percentage of participants
Interval 75.0 to 84.4
|
79.0 Percentage of participants
Interval 74.2 to 83.8
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
78.6 Percentage of participants
Interval 73.8 to 83.4
|
78.3 Percentage of participants
Interval 73.5 to 83.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
83.3 Percentage of participants
Interval 79.0 to 87.7
|
76.9 Percentage of participants
Interval 71.9 to 81.9
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
82.6 Percentage of participants
Interval 78.2 to 87.0
|
79.4 Percentage of participants
Interval 74.6 to 84.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
81.5 Percentage of participants
Interval 77.0 to 86.0
|
79.4 Percentage of participants
Interval 74.6 to 84.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
76.4 Percentage of participants
Interval 71.5 to 81.3
|
78.3 Percentage of participants
Interval 73.5 to 83.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
79.0 Percentage of participants
Interval 74.2 to 83.7
|
77.2 Percentage of participants
Interval 72.3 to 82.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
77.9 Percentage of participants
Interval 73.0 to 82.8
|
76.1 Percentage of participants
Interval 71.1 to 81.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
78.2 Percentage of participants
Interval 73.4 to 83.1
|
76.5 Percentage of participants
Interval 71.6 to 81.5
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
77.5 Percentage of participants
Interval 72.7 to 82.4
|
77.6 Percentage of participants
Interval 72.7 to 82.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72Population: Intent-to-Treat (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 from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=277 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
46.4 Percentage of participants
Interval 40.6 to 52.3
|
51.3 Percentage of participants
Interval 45.4 to 57.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
55.4 Percentage of participants
Interval 49.6 to 61.2
|
54.2 Percentage of participants
Interval 48.3 to 60.0
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
55.1 Percentage of participants
Interval 49.2 to 60.9
|
52.7 Percentage of participants
Interval 46.9 to 58.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
56.2 Percentage of participants
Interval 50.4 to 62.0
|
55.2 Percentage of participants
Interval 49.4 to 61.1
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
62.4 Percentage of participants
Interval 56.7 to 68.0
|
56.0 Percentage of participants
Interval 50.1 to 61.8
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
63.8 Percentage of participants
Interval 58.2 to 69.4
|
56.6 Percentage of participants
Interval 50.9 to 62.4
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
59.8 Percentage of participants
Interval 54.1 to 65.5
|
58.5 Percentage of participants
Interval 52.7 to 64.3
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
57.2 Percentage of participants
Interval 51.5 to 63.0
|
57.4 Percentage of participants
Interval 51.5 to 63.2
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
58.0 Percentage of participants
Interval 52.1 to 63.8
|
60.3 Percentage of participants
Interval 54.5 to 66.0
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
62.0 Percentage of participants
Interval 56.3 to 67.7
|
56.6 Percentage of participants
Interval 50.8 to 62.5
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
60.9 Percentage of participants
Interval 55.1 to 66.6
|
58.8 Percentage of participants
Interval 53.1 to 64.6
|
—
|
—
|
|
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
63.0 Percentage of participants
Interval 57.4 to 68.7
|
58.1 Percentage of participants
Interval 52.3 to 63.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 68Population: The analysis population included all randomized participants who had not discontinued the study at Week 68.
In Part 2 of the study, participants in both the faricimab Q4W and aflibercept Q4W arms in Part 1 received 6 mg faricimab intravitreal injections administered according to a personalized treatment interval (PTI) dosing regimen in intervals between Q4W and Q16W. At faricimab dosing visits, treatment intervals were maintained or adjusted (i.e., increased by 4 weeks or decreased by 4, 8, or 12 weeks), based on central subfield thickness (CST) and BCVA values.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=248 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=244 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 4 Weeks (Q4W)
|
22.6 Percentage of participants
Interval 17.4 to 27.8
|
25.0 Percentage of participants
Interval 19.6 to 30.4
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 8 Weeks (Q8W)
|
13.3 Percentage of participants
Interval 9.1 to 17.5
|
18.0 Percentage of participants
Interval 13.2 to 22.9
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 12 Weeks (Q12W)
|
11.7 Percentage of participants
Interval 7.7 to 15.7
|
9.4 Percentage of participants
Interval 5.8 to 13.1
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 16 Weeks (Q16W)
|
52.4 Percentage of participants
Interval 46.2 to 58.6
|
47.5 Percentage of participants
Interval 41.3 to 53.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week 24 to Week 72Population: Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, all participants who received at least one faricimab dose.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=270 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=267 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72
|
4.0 Injections
Interval 1.0 to 12.0
|
4.0 Injections
Interval 1.0 to 12.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72Population: Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 were excluded); in Arm B, all participants who received at least one faricimab dose (7 were excluded).
This analysis of adverse events (AEs) only includes ocular AEs that occurred in the study 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 |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=274 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=270 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
n=267 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Adverse Event (AE)
|
45 Participants
|
56 Participants
|
76 Participants
|
81 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AE by Severity: Mild
|
40 Participants
|
47 Participants
|
50 Participants
|
64 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AE by Severity: Moderate
|
4 Participants
|
8 Participants
|
25 Participants
|
16 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AE by Severity: Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AE by Severity: Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Serious Adverse Event (SAE)
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AE Leading to Withdrawal from Study Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Treatment Related AEs
|
1 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Treatment Related SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Any AE of Special Interest (AESI)
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AESI: Drop in Visual Acuity Score ≥30
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72Population: Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 excluded); in Arm B, all participants who received at least one faricimab dose (7 excluded).
This analysis of adverse events (AEs) only includes ocular AEs that occurred in 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 |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=274 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=270 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
n=267 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Incidence of Ocular Adverse Events in the Fellow Eye
Adverse Event (AE)
|
25 Participants
|
21 Participants
|
37 Participants
|
30 Participants
|
|
Incidence of Ocular Adverse Events in the Fellow Eye
Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Ocular Adverse Events in the Fellow Eye
Any AE of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72Population: Safety-Evaluable Population: All participants randomized in the study who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, the safety analysis included: in Arm A, all participants with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168 (6 excluded); in Arm B, all participants who received at least one faricimab dose (7 excluded).
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 |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=274 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=270 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
n=267 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Incidence of Non-Ocular Adverse Events
Any AE of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Non-Ocular Adverse Events
Adverse Event (AE)
|
94 Participants
|
99 Participants
|
136 Participants
|
126 Participants
|
|
Incidence of Non-Ocular Adverse Events
Serious Adverse Event (SAE)
|
9 Participants
|
16 Participants
|
25 Participants
|
23 Participants
|
|
Incidence of Non-Ocular Adverse Events
AE Leading to Withdrawal from Study Treatment
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72Population: Pharmacokinetic-Evaluable Population: All safety- evaluable participants randomized to faricimab arm or who received faricimab with at least one plasma sample, provided sufficient dosing information (dose and dosing time) is available. The number analyzed indicates all participants who provided a PK sample at a given timepoint.
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=268 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Plasma Concentration of Faricimab Over Time
Baseline
|
0.0000 microgram per millilitre (μg/mL)
Standard Deviation 0.0000
|
—
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 4
|
0.0215 microgram per millilitre (μg/mL)
Standard Deviation 0.0160
|
—
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 24
|
0.0220 microgram per millilitre (μg/mL)
Standard Deviation 0.0181
|
0.0005 microgram per millilitre (μg/mL)
Standard Deviation 0.0006
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 28
|
0.0040 microgram per millilitre (μg/mL)
Standard Deviation 0.0072
|
0.0025 microgram per millilitre (μg/mL)
Standard Deviation 0.077
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 52
|
0.0061 microgram per millilitre (μg/mL)
Standard Deviation 0.0110
|
0.0097 microgram per millilitre (μg/mL)
Standard Deviation 0.0156
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 72
|
0.0076 microgram per millilitre (μg/mL)
Standard Deviation 0.0109
|
0.0087 microgram per millilitre (μg/mL)
Standard Deviation 0.0146
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72Population: The immunogenicity analysis included all participants with an evaluable ADA sample. At baseline, evaluable participants were those with an ADA sample prior to faricimab injection, including those who did not receive study treatment; post-baseline, evaluable participants were those with an ADA sample after having received at least one dose of faricimab.
Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The number 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. Treatment-unaffected ADA-positive is a post-baseline sample with a titer that is lower than 4-fold the ADA-positive baseline titer (faricimab arm) or the ADA-positive titer prior to first faricimab injection (aflibercept arm).
Outcome measures
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=274 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=266 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=540 Participants
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Baseline (BL): Total ADA-Positive
|
3 Participants
|
4 Participants
|
7 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Post-BL: Total ADA-Positive
|
33 Participants
|
23 Participants
|
56 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Post-BL: Treatment-Emergent ADA-Positive
|
32 Participants
|
21 Participants
|
53 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Post-BL: Treatment-Unaffected ADA-Positive
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
Adverse Events
Arm A: Faricimab Q4W (Part 1)
Serious events: 12 serious events
Other events: 62 other events
Deaths: 1 deaths
Arm B: Aflibercept Q4W (Part 1)
Serious events: 17 serious events
Other events: 69 other events
Deaths: 0 deaths
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
Serious events: 29 serious events
Other events: 92 other events
Deaths: 1 deaths
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
Serious events: 26 serious events
Other events: 87 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=274 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=270 participants at risk
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
n=267 participants at risk
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.73%
2/274 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.74%
2/270 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal ischaemia
|
0.72%
2/276 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.75%
2/267 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal vein occlusion
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.73%
2/274 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Investigations
Blood pressure increased
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral infarction
|
1.1%
3/276 • Number of events 3 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.75%
2/267 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Reproductive system and breast disorders
Urogenital prolapse
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.74%
2/270 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Congenital, familial and genetic disorders
Vertebral artery hypoplasia
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Macular ischaemia
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Macular oedema
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Tractional retinal detachment
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
General disorders
Death
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
General disorders
Pain
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Sepsis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.74%
2/270 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.74%
2/270 • Number of events 3 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.75%
2/267 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Product Issues
Device malfunction
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/267 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/274 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.37%
1/270 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/267 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
Other adverse events
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=276 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A were to receive faricimab 6 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm B: Aflibercept Q4W (Part 1)
n=274 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B were to receive aflibercept 2 milligrams (mg) administered by intravitreal (IVT) injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
|
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
n=270 participants at risk
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
n=267 participants at risk
In Part 2 (from Week 24 to Week 72), participants received faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure was to be administered during study visits at which no faricimab treatment was administered (according to the PTI dosing regimen).
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
3.6%
10/276 • Number of events 10 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
5.8%
16/274 • Number of events 16 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
11.9%
32/270 • Number of events 32 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
9.4%
25/267 • Number of events 25 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertension
|
7.2%
20/276 • Number of events 21 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.6%
7/274 • Number of events 7 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
5.2%
14/270 • Number of events 14 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.0%
8/267 • Number of events 8 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Conjunctival haemorrhage
|
2.9%
8/276 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.6%
10/274 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
4.1%
11/270 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.7%
10/267 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Dry eye
|
1.8%
5/276 • Number of events 5 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.3%
9/274 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.5%
4/270 • Number of events 5 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.5%
4/267 • Number of events 4 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.72%
2/276 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.6%
10/274 • Number of events 10 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.9%
5/270 • Number of events 6 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.5%
4/267 • Number of events 4 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
6/276 • Number of events 6 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.2%
6/274 • Number of events 6 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.6%
7/270 • Number of events 8 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.7%
10/267 • Number of events 12 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
4/276 • Number of events 4 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.8%
5/274 • Number of events 5 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.2%
6/270 • Number of events 8 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.4%
9/267 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract
|
0.72%
2/276 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.36%
1/274 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.3%
9/270 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.4%
9/267 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous detachment
|
1.4%
4/276 • Number of events 4 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.73%
2/274 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.6%
7/270 • Number of events 7 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.4%
9/267 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/276 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.73%
2/274 • Number of events 3 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.3%
9/270 • Number of events 12 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.0%
8/267 • Number of events 10 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Investigations
Intraocular pressure increased
|
0.36%
1/276 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.9%
8/274 • Number of events 8 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
4.8%
13/270 • Number of events 21 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.0%
8/267 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous floaters
|
2.5%
7/276 • Number of events 7 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.2%
6/274 • Number of events 6 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.00%
0/270 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.4%
9/267 • Number of events 9 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Eye disorders
Macular oedema
|
0.36%
1/276 • Number of events 1 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.73%
2/274 • Number of events 2 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
3.7%
10/270 • Number of events 11 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
1.9%
5/267 • Number of events 8 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have 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