Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion (NCT NCT04740931)
NCT ID: NCT04740931
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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
729 participants
Primary outcome timeframe
From Baseline through Week 24
Results posted on
2024-08-06
Participant Flow
Participant milestones
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is 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 randomly assigned to Arm B will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
|
|---|---|---|
|
Part 1 (Baseline up to Week 24)
STARTED
|
366
|
363
|
|
Part 1 (Baseline up to Week 24)
Received at Least One Dose of Study Drug
|
365
|
361
|
|
Part 1 (Baseline up to Week 24)
COMPLETED
|
360
|
353
|
|
Part 1 (Baseline up to Week 24)
NOT COMPLETED
|
6
|
10
|
|
Part 2 (Week 24 to Week 72)
STARTED
|
360
|
353
|
|
Part 2 (Week 24 to Week 72)
COMPLETED
|
333
|
323
|
|
Part 2 (Week 24 to Week 72)
NOT COMPLETED
|
27
|
30
|
Reasons for withdrawal
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is 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 randomly assigned to Arm B will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
|
|---|---|---|
|
Part 1 (Baseline up to Week 24)
Withdrawal by Subject
|
0
|
4
|
|
Part 1 (Baseline up to Week 24)
Death
|
1
|
2
|
|
Part 1 (Baseline up to Week 24)
Non-compliance with study drug
|
2
|
0
|
|
Part 1 (Baseline up to Week 24)
Reason Not Specified
|
2
|
0
|
|
Part 1 (Baseline up to Week 24)
Adverse Event
|
1
|
1
|
|
Part 1 (Baseline up to Week 24)
Protocol Violation
|
0
|
1
|
|
Part 1 (Baseline up to Week 24)
Physician Decision
|
0
|
1
|
|
Part 1 (Baseline up to Week 24)
Lost to Follow-up
|
0
|
1
|
|
Part 2 (Week 24 to Week 72)
Withdrawal by Subject
|
11
|
11
|
|
Part 2 (Week 24 to Week 72)
Lost to Follow-up
|
3
|
9
|
|
Part 2 (Week 24 to Week 72)
Adverse Event
|
5
|
5
|
|
Part 2 (Week 24 to Week 72)
Death
|
4
|
1
|
|
Part 2 (Week 24 to Week 72)
Other
|
1
|
3
|
|
Part 2 (Week 24 to Week 72)
Physician Decision
|
2
|
1
|
|
Part 2 (Week 24 to Week 72)
Non-compliance with study drug
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Baseline characteristics by cohort
| Measure |
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
n=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
|
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
n=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will 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 will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).
|
Total
n=729 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
64.7 Years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
65.1 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
336 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
200 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
286 Participants
n=5 Participants
|
283 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
89 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
243 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Rest of World
|
187 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Region of Enrollment
USA and Canada
|
95 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Region of Enrollment
Asia
|
84 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
Left Eye
|
180 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Left or Right) Chosen as the Study Eye
Right Eye
|
186 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
|
50.25 ETDRS Letters
STANDARD_DEVIATION 16.25 • n=5 Participants
|
50.71 ETDRS Letters
STANDARD_DEVIATION 16.34 • n=7 Participants
|
50.48 ETDRS Letters
STANDARD_DEVIATION 16.29 • n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≤34 Letters (20/200 or Worse)
|
79 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
>34 Letters to <55 Letters
|
106 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≥55 Letters (20/80 or Better)
|
181 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
359 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 15.4 to 18.3
|
17.3 ETDRS Letters
Interval 15.9 to 18.8
|
—
|
—
|
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 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
13.5 ETDRS Letters
Interval 12.5 to 14.6
|
14.3 ETDRS Letters
Interval 13.2 to 15.4
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
15.5 ETDRS Letters
Interval 14.4 to 16.7
|
16.5 ETDRS Letters
Interval 15.3 to 17.7
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
16.9 ETDRS Letters
Interval 15.7 to 18.2
|
17.1 ETDRS Letters
Interval 15.8 to 18.4
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
16.8 ETDRS Letters
Interval 15.4 to 18.1
|
17.5 ETDRS Letters
Interval 16.2 to 18.9
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
17.0 ETDRS Letters
Interval 15.6 to 18.3
|
17.2 ETDRS Letters
Interval 15.8 to 18.5
|
—
|
—
|
|
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
16.9 ETDRS Letters
Interval 15.4 to 18.3
|
17.3 ETDRS Letters
Interval 15.9 to 18.8
|
—
|
—
|
SECONDARY 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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
56.6 Percentage of participants
Interval 51.7 to 61.5
|
58.1 Percentage of participants
Interval 53.3 to 62.9
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
41.5 Percentage of participants
Interval 36.7 to 46.3
|
45.4 Percentage of participants
Interval 40.7 to 50.2
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
51.1 Percentage of participants
Interval 46.3 to 55.9
|
53.7 Percentage of participants
Interval 48.9 to 58.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
54.6 Percentage of participants
Interval 49.8 to 59.4
|
55.1 Percentage of participants
Interval 50.3 to 59.9
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
57.7 Percentage of participants
Interval 52.8 to 62.5
|
59.5 Percentage of participants
Interval 54.7 to 64.3
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
56.6 Percentage of participants
Interval 51.7 to 61.4
|
57.8 Percentage of participants
Interval 53.0 to 62.6
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
56.6 Percentage of participants
Interval 51.7 to 61.5
|
58.1 Percentage of participants
Interval 53.3 to 62.9
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
60.9 Percentage of participants
Interval 56.0 to 65.8
|
62.3 Percentage of participants
Interval 57.6 to 66.9
|
—
|
—
|
|
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 64.5 to 73.7
|
72.8 Percentage of participants
Interval 68.3 to 77.2
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
73.2 Percentage of participants
Interval 68.8 to 77.7
|
74.7 Percentage of participants
Interval 70.3 to 79.0
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
73.5 Percentage of participants
Interval 69.1 to 78.0
|
75.8 Percentage of participants
Interval 71.4 to 80.1
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
72.4 Percentage of participants
Interval 68.0 to 76.9
|
74.1 Percentage of participants
Interval 69.7 to 78.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
72.2 Percentage of participants
Interval 67.7 to 76.6
|
73.3 Percentage of participants
Interval 68.8 to 77.7
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
86.3 Percentage of participants
Interval 82.9 to 89.8
|
88.7 Percentage of participants
Interval 85.5 to 92.0
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
83.1 Percentage of participants
Interval 79.3 to 86.9
|
83.5 Percentage of participants
Interval 79.7 to 87.2
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
85.2 Percentage of participants
Interval 81.7 to 88.8
|
86.8 Percentage of participants
Interval 83.3 to 90.2
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
87.4 Percentage of participants
Interval 84.1 to 90.8
|
87.1 Percentage of participants
Interval 83.7 to 90.5
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
84.1 Percentage of participants
Interval 80.5 to 87.8
|
86.5 Percentage of participants
Interval 83.0 to 90.0
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
85.3 Percentage of participants
Interval 81.8 to 88.8
|
84.6 Percentage of participants
Interval 80.9 to 88.2
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
92.1 Percentage of participants
Interval 89.4 to 94.8
|
94.8 Percentage of participants
Interval 92.5 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
|
92.6 Percentage of participants
Interval 90.0 to 95.3
|
92.0 Percentage of participants
Interval 89.3 to 94.8
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
91.4 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
92.1 Percentage of participants
Interval 89.4 to 94.8
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
92.6 Percentage of participants
Interval 89.9 to 95.2
|
—
|
—
|
|
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
89.2 Percentage of participants
Interval 86.1 to 92.4
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
97.3 Percentage of participants
Interval 95.6 to 98.9
|
97.0 Percentage of participants
Interval 95.2 to 98.7
|
—
|
—
|
|
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
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
—
|
—
|
|
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
|
96.2 Percentage of participants
Interval 94.3 to 98.1
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
—
|
—
|
|
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
|
98.4 Percentage of participants
Interval 97.1 to 99.7
|
98.9 Percentage of participants
Interval 97.8 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
|
98.1 Percentage of participants
Interval 96.7 to 99.5
|
98.1 Percentage of participants
Interval 96.7 to 99.5
|
—
|
—
|
|
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
|
98.6 Percentage of participants
Interval 97.5 to 99.8
|
97.5 Percentage of participants
Interval 95.9 to 99.1
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
98.1 Percentage of participants
Interval 96.7 to 99.5
|
98.6 Percentage of participants
Interval 97.4 to 99.8
|
—
|
—
|
|
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
|
97.8 Percentage of participants
Interval 96.3 to 99.3
|
97.0 Percentage of participants
Interval 95.2 to 98.7
|
—
|
—
|
|
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 16
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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
|
95.1 Percentage of participants
Interval 92.9 to 97.3
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 8
|
97.5 Percentage of participants
Interval 96.0 to 99.1
|
97.5 Percentage of participants
Interval 95.9 to 99.1
|
—
|
—
|
|
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
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
96.2 Percentage of participants
Interval 94.2 to 98.1
|
96.4 Percentage of participants
Interval 94.5 to 98.3
|
—
|
—
|
|
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
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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
|
95.4 Percentage of participants
Interval 93.2 to 97.5
|
94.8 Percentage of participants
Interval 92.5 to 97.0
|
—
|
—
|
|
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 4
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
98.1 Percentage of participants
Interval 96.7 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 20
|
94.8 Percentage of participants
Interval 92.6 to 97.1
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
93.7 Percentage of participants
Interval 91.2 to 96.1
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
8.7 Percentage of participants
Interval 5.9 to 11.5
|
10.2 Percentage of participants
Interval 7.2 to 13.2
|
—
|
—
|
|
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
|
10.9 Percentage of participants
Interval 7.8 to 14.0
|
11.9 Percentage of participants
Interval 8.7 to 15.0
|
—
|
—
|
|
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
|
14.2 Percentage of participants
Interval 10.9 to 17.6
|
14.9 Percentage of participants
Interval 11.4 to 18.3
|
—
|
—
|
|
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
|
6.0 Percentage of participants
Interval 3.6 to 8.4
|
4.7 Percentage of participants
Interval 2.6 to 6.8
|
—
|
—
|
|
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 16
|
11.5 Percentage of participants
Interval 8.4 to 14.6
|
14.1 Percentage of participants
Interval 10.7 to 17.5
|
—
|
—
|
|
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
|
14.5 Percentage of participants
Interval 11.0 to 17.9
|
15.2 Percentage of participants
Interval 11.7 to 18.7
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 12
|
54.9 Percentage of participants
Interval 50.8 to 58.9
|
55.7 Percentage of participants
Interval 51.4 to 60.0
|
—
|
—
|
|
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
|
54.9 Percentage of participants
Interval 50.6 to 59.1
|
59.3 Percentage of participants
Interval 55.2 to 63.4
|
—
|
—
|
|
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
|
55.7 Percentage of participants
Interval 51.3 to 60.0
|
59.0 Percentage of participants
Interval 54.5 to 63.4
|
—
|
—
|
|
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
|
45.0 Percentage of participants
Interval 41.0 to 49.1
|
46.1 Percentage of participants
Interval 41.9 to 50.2
|
—
|
—
|
|
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
|
48.6 Percentage of participants
Interval 44.3 to 52.8
|
54.6 Percentage of participants
Interval 50.5 to 58.7
|
—
|
—
|
|
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
|
54.1 Percentage of participants
Interval 49.7 to 58.4
|
57.6 Percentage of participants
Interval 53.4 to 61.8
|
—
|
—
|
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 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
7.8 Percentage of participants
Interval 5.3 to 10.4
|
6.2 Percentage of participants
Interval 3.8 to 8.5
|
—
|
—
|
|
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
|
8.4 Percentage of participants
Interval 5.7 to 11.0
|
6.4 Percentage of participants
Interval 4.0 to 8.8
|
—
|
—
|
|
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 4
|
10.0 Percentage of participants
Interval 7.3 to 12.8
|
8.6 Percentage of participants
Interval 6.1 to 11.1
|
—
|
—
|
|
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
|
8.2 Percentage of participants
Interval 5.5 to 10.8
|
7.0 Percentage of participants
Interval 4.6 to 9.4
|
—
|
—
|
|
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
|
7.3 Percentage of participants
Interval 4.9 to 9.8
|
6.4 Percentage of participants
Interval 4.0 to 8.8
|
—
|
—
|
|
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 24
|
10.1 Percentage of participants
Interval 7.1 to 13.0
|
7.5 Percentage of participants
Interval 4.9 to 10.1
|
—
|
—
|
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.
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the Bruch's membrane (BM) 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
-420.8 microns
Interval -429.2 to -412.5
|
-417.3 microns
Interval -425.6 to -409.0
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
-451.0 microns
Interval -460.6 to -441.5
|
-442.5 microns
Interval -452.1 to -433.0
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
-452.5 microns
Interval -461.8 to -443.1
|
-445.2 microns
Interval -454.7 to -435.8
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
-459.4 microns
Interval -467.8 to -451.0
|
-445.1 microns
Interval -453.6 to -436.6
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
-444.2 microns
Interval -452.7 to -435.7
|
-437.5 microns
Interval -446.1 to -429.0
|
—
|
—
|
|
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
-461.6 microns
Interval -471.4 to -451.9
|
-448.8 microns
Interval -458.6 to -439.0
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
83.8 Percentage of participants
Interval 80.2 to 87.5
|
82.4 Percentage of participants
Interval 78.5 to 86.2
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
92.6 Percentage of participants
Interval 90.0 to 95.2
|
91.2 Percentage of participants
Interval 88.3 to 94.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
91.5 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 16
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
92.8 Percentage of participants
Interval 90.2 to 95.5
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
94.8 Percentage of participants
Interval 92.6 to 97.1
|
93.1 Percentage of participants
Interval 90.5 to 95.7
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
93.7 Percentage of participants
Interval 91.2 to 96.2
|
92.0 Percentage of participants
Interval 89.2 to 94.7
|
—
|
—
|
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 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
55.4 Percentage of participants
Interval 50.5 to 60.3
|
51.9 Percentage of participants
Interval 46.8 to 56.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
59.0 Percentage of participants
Interval 54.0 to 63.9
|
56.5 Percentage of participants
Interval 51.6 to 61.5
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
45.5 Percentage of participants
Interval 40.6 to 50.5
|
40.3 Percentage of participants
Interval 35.6 to 45.0
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 8
|
63.1 Percentage of participants
Interval 58.3 to 68.0
|
61.7 Percentage of participants
Interval 56.9 to 66.6
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
53.2 Percentage of participants
Interval 48.3 to 58.2
|
51.0 Percentage of participants
Interval 46.2 to 55.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
76.2 Percentage of participants
Interval 71.9 to 80.5
|
70.8 Percentage of participants
Interval 66.2 to 75.4
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
89.6 Percentage of participants
Interval 86.5 to 92.6
|
90.1 Percentage of participants
Interval 87.0 to 93.1
|
—
|
—
|
|
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 93.2 to 97.5
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
96.4 Percentage of participants
Interval 94.6 to 98.3
|
93.4 Percentage of participants
Interval 90.8 to 95.9
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 4
|
66.1 Percentage of participants
Interval 61.4 to 70.8
|
65.0 Percentage of participants
Interval 60.3 to 69.7
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 12
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
33.0 Percentage of participants
Interval 28.3 to 37.6
|
29.3 Percentage of participants
Interval 24.9 to 33.7
|
—
|
—
|
|
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
|
54.9 Percentage of participants
Interval 49.9 to 59.8
|
51.3 Percentage of participants
Interval 46.3 to 56.3
|
—
|
—
|
|
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
|
59.3 Percentage of participants
Interval 54.4 to 64.1
|
59.3 Percentage of participants
Interval 54.3 to 64.2
|
—
|
—
|
|
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
|
52.7 Percentage of participants
Interval 47.7 to 57.6
|
50.2 Percentage of participants
Interval 45.3 to 55.1
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 20
|
58.2 Percentage of participants
Interval 53.2 to 63.1
|
55.4 Percentage of participants
Interval 50.5 to 60.4
|
—
|
—
|
|
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Week 24
|
75.1 Percentage of participants
Interval 70.8 to 79.5
|
68.6 Percentage of participants
Interval 63.8 to 73.4
|
—
|
—
|
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=339 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=330 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
6.9 score on a scale
Interval 5.8 to 8.0
|
8.1 score on a scale
Interval 7.0 to 9.2
|
—
|
—
|
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 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 40
|
15.8 ETDRS Letters
Interval 14.2 to 17.5
|
16.2 ETDRS Letters
Interval 14.5 to 17.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
16.9 ETDRS Letters
Interval 15.1 to 18.6
|
17.1 ETDRS Letters
Interval 15.3 to 18.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
13.6 ETDRS Letters
Interval 12.5 to 14.6
|
14.3 ETDRS Letters
Interval 13.3 to 15.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
15.6 ETDRS Letters
Interval 14.4 to 16.8
|
16.5 ETDRS Letters
Interval 15.4 to 17.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
17.0 ETDRS Letters
Interval 15.7 to 18.2
|
17.2 ETDRS Letters
Interval 15.9 to 18.4
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
16.8 ETDRS Letters
Interval 15.5 to 18.1
|
17.6 ETDRS Letters
Interval 16.2 to 18.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
17.0 ETDRS Letters
Interval 15.7 to 18.4
|
17.3 ETDRS Letters
Interval 15.9 to 18.6
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
16.9 ETDRS Letters
Interval 15.5 to 18.3
|
17.3 ETDRS Letters
Interval 15.9 to 18.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
16.0 ETDRS Letters
Interval 14.5 to 17.5
|
16.0 ETDRS Letters
Interval 14.4 to 17.5
|
—
|
—
|
|
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 15.7 to 18.7
|
17.5 ETDRS Letters
Interval 16.0 to 19.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
17.0 ETDRS Letters
Interval 15.5 to 18.5
|
17.5 ETDRS Letters
Interval 15.9 to 19.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
16.5 ETDRS Letters
Interval 14.9 to 18.2
|
17.3 ETDRS Letters
Interval 15.7 to 19.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
16.9 ETDRS Letters
Interval 15.2 to 18.5
|
17.6 ETDRS Letters
Interval 15.9 to 19.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
16.4 ETDRS Letters
Interval 14.8 to 18.1
|
17.8 ETDRS Letters
Interval 16.2 to 19.5
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
16.0 ETDRS Letters
Interval 14.3 to 17.7
|
16.9 ETDRS Letters
Interval 15.2 to 18.6
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
16.9 ETDRS Letters
Interval 15.2 to 18.6
|
17.3 ETDRS Letters
Interval 15.6 to 19.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
16.8 ETDRS Letters
Interval 15.1 to 18.5
|
17.2 ETDRS Letters
Interval 15.5 to 18.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
16.9 ETDRS Letters
Interval 15.2 to 18.7
|
17.0 ETDRS Letters
Interval 15.2 to 18.7
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
51.1 Percentage of participants
Interval 46.3 to 55.9
|
53.7 Percentage of participants
Interval 48.9 to 58.5
|
—
|
—
|
|
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 12
|
54.6 Percentage of participants
Interval 49.8 to 59.4
|
55.1 Percentage of participants
Interval 50.3 to 59.9
|
—
|
—
|
|
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 20
|
56.6 Percentage of participants
Interval 51.7 to 61.4
|
57.8 Percentage of participants
Interval 53.0 to 62.6
|
—
|
—
|
|
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
|
56.6 Percentage of participants
Interval 51.7 to 61.5
|
58.1 Percentage of participants
Interval 53.3 to 62.9
|
—
|
—
|
|
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 28
|
53.3 Percentage of participants
Interval 48.4 to 58.2
|
54.8 Percentage of participants
Interval 50.0 to 59.6
|
—
|
—
|
|
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 36
|
58.2 Percentage of participants
Interval 53.3 to 63.1
|
58.9 Percentage of participants
Interval 54.2 to 63.7
|
—
|
—
|
|
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 40
|
56.6 Percentage of participants
Interval 51.7 to 61.4
|
55.9 Percentage of participants
Interval 51.1 to 60.7
|
—
|
—
|
|
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 60
|
58.2 Percentage of participants
Interval 53.3 to 63.1
|
59.0 Percentage of participants
Interval 54.1 to 63.8
|
—
|
—
|
|
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 64
|
57.1 Percentage of participants
Interval 52.3 to 61.9
|
59.5 Percentage of participants
Interval 54.7 to 64.3
|
—
|
—
|
|
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 4
|
41.5 Percentage of participants
Interval 36.7 to 46.3
|
45.2 Percentage of participants
Interval 40.4 to 49.9
|
—
|
—
|
|
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 16
|
57.7 Percentage of participants
Interval 52.8 to 62.5
|
59.5 Percentage of participants
Interval 54.7 to 64.3
|
—
|
—
|
|
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 32
|
60.9 Percentage of participants
Interval 56.1 to 65.8
|
57.6 Percentage of participants
Interval 52.7 to 62.4
|
—
|
—
|
|
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 44
|
55.7 Percentage of participants
Interval 50.9 to 60.6
|
57.3 Percentage of participants
Interval 52.5 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 48
|
58.8 Percentage of participants
Interval 53.9 to 63.6
|
58.1 Percentage of participants
Interval 53.3 to 62.9
|
—
|
—
|
|
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 52
|
57.6 Percentage of participants
Interval 52.7 to 62.5
|
58.7 Percentage of participants
Interval 53.8 to 63.5
|
—
|
—
|
|
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
|
56.3 Percentage of participants
Interval 51.3 to 61.2
|
57.3 Percentage of participants
Interval 52.5 to 62.2
|
—
|
—
|
|
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 68
|
56.8 Percentage of participants
Interval 52.0 to 61.6
|
59.8 Percentage of participants
Interval 54.9 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 72
|
58.7 Percentage of participants
Interval 53.9 to 63.6
|
60.0 Percentage of participants
Interval 55.2 to 64.9
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
60.9 Percentage of participants
Interval 56.0 to 65.8
|
62.3 Percentage of participants
Interval 57.6 to 66.9
|
—
|
—
|
|
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 20
|
72.4 Percentage of participants
Interval 68.0 to 76.9
|
74.1 Percentage of participants
Interval 69.7 to 78.5
|
—
|
—
|
|
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
|
71.9 Percentage of participants
Interval 67.3 to 76.4
|
75.5 Percentage of participants
Interval 71.1 to 79.9
|
—
|
—
|
|
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 56
|
70.8 Percentage of participants
Interval 66.2 to 75.3
|
72.2 Percentage of participants
Interval 67.6 to 76.7
|
—
|
—
|
|
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 64.5 to 73.7
|
72.8 Percentage of participants
Interval 68.3 to 77.2
|
—
|
—
|
|
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 12
|
73.2 Percentage of participants
Interval 68.8 to 77.7
|
74.7 Percentage of participants
Interval 70.3 to 79.0
|
—
|
—
|
|
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
|
73.5 Percentage of participants
Interval 69.1 to 78.0
|
75.8 Percentage of participants
Interval 71.4 to 80.1
|
—
|
—
|
|
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
|
72.2 Percentage of participants
Interval 67.7 to 76.6
|
73.3 Percentage of participants
Interval 68.8 to 77.7
|
—
|
—
|
|
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
|
69.7 Percentage of participants
Interval 65.1 to 74.3
|
70.5 Percentage of participants
Interval 66.0 to 75.1
|
—
|
—
|
|
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
|
73.0 Percentage of participants
Interval 68.5 to 77.4
|
74.4 Percentage of participants
Interval 70.0 to 78.8
|
—
|
—
|
|
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 36
|
73.8 Percentage of participants
Interval 69.3 to 78.2
|
74.9 Percentage of participants
Interval 70.6 to 79.3
|
—
|
—
|
|
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
|
71.0 Percentage of participants
Interval 66.5 to 75.6
|
73.0 Percentage of participants
Interval 68.6 to 77.5
|
—
|
—
|
|
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 44
|
71.6 Percentage of participants
Interval 67.1 to 76.1
|
74.1 Percentage of participants
Interval 69.7 to 78.5
|
—
|
—
|
|
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 52
|
71.0 Percentage of participants
Interval 66.4 to 75.6
|
73.8 Percentage of participants
Interval 69.4 to 78.3
|
—
|
—
|
|
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
|
72.7 Percentage of participants
Interval 68.2 to 77.2
|
72.5 Percentage of participants
Interval 67.9 to 77.0
|
—
|
—
|
|
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
|
72.4 Percentage of participants
Interval 67.9 to 76.9
|
71.6 Percentage of participants
Interval 67.0 to 76.2
|
—
|
—
|
|
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 68
|
72.1 Percentage of participants
Interval 67.7 to 76.6
|
70.5 Percentage of participants
Interval 65.9 to 75.1
|
—
|
—
|
|
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
|
71.6 Percentage of participants
Interval 67.1 to 76.1
|
73.0 Percentage of participants
Interval 68.5 to 77.5
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 28
|
81.7 Percentage of participants
Interval 77.8 to 85.6
|
84.0 Percentage of participants
Interval 80.3 to 87.7
|
—
|
—
|
|
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 56
|
79.2 Percentage of participants
Interval 75.2 to 83.3
|
81.5 Percentage of participants
Interval 77.6 to 85.5
|
—
|
—
|
|
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 60
|
82.8 Percentage of participants
Interval 79.0 to 86.6
|
81.6 Percentage of participants
Interval 77.6 to 85.5
|
—
|
—
|
|
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 4
|
83.1 Percentage of participants
Interval 79.3 to 86.9
|
83.5 Percentage of participants
Interval 79.7 to 87.2
|
—
|
—
|
|
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 8
|
85.2 Percentage of participants
Interval 81.7 to 88.8
|
86.8 Percentage of participants
Interval 83.3 to 90.2
|
—
|
—
|
|
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 12
|
87.4 Percentage of participants
Interval 84.1 to 90.8
|
87.1 Percentage of participants
Interval 83.7 to 90.5
|
—
|
—
|
|
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 16
|
86.3 Percentage of participants
Interval 82.9 to 89.8
|
88.7 Percentage of participants
Interval 85.5 to 92.0
|
—
|
—
|
|
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 20
|
84.1 Percentage of participants
Interval 80.5 to 87.8
|
86.5 Percentage of participants
Interval 83.0 to 90.0
|
—
|
—
|
|
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 24
|
85.3 Percentage of participants
Interval 81.8 to 88.8
|
84.6 Percentage of participants
Interval 80.9 to 88.2
|
—
|
—
|
|
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 32
|
84.2 Percentage of participants
Interval 80.5 to 87.8
|
87.3 Percentage of participants
Interval 83.9 to 90.7
|
—
|
—
|
|
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 36
|
84.7 Percentage of participants
Interval 81.1 to 88.3
|
85.7 Percentage of participants
Interval 82.1 to 89.3
|
—
|
—
|
|
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
|
82.3 Percentage of participants
Interval 78.4 to 86.1
|
84.3 Percentage of participants
Interval 80.6 to 88.0
|
—
|
—
|
|
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
|
82.8 Percentage of participants
Interval 79.0 to 86.6
|
84.9 Percentage of participants
Interval 81.2 to 88.5
|
—
|
—
|
|
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 48
|
83.6 Percentage of participants
Interval 79.9 to 87.3
|
83.7 Percentage of participants
Interval 80.0 to 87.5
|
—
|
—
|
|
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 52
|
80.9 Percentage of participants
Interval 76.9 to 84.8
|
84.0 Percentage of participants
Interval 80.3 to 87.8
|
—
|
—
|
|
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 64
|
80.6 Percentage of participants
Interval 76.6 to 84.6
|
81.5 Percentage of participants
Interval 77.6 to 85.5
|
—
|
—
|
|
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 68
|
83.3 Percentage of participants
Interval 79.6 to 87.1
|
80.2 Percentage of participants
Interval 76.1 to 84.2
|
—
|
—
|
|
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 72
|
83.6 Percentage of participants
Interval 79.9 to 87.3
|
79.6 Percentage of participants
Interval 75.5 to 83.7
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 48
|
88.5 Percentage of participants
Interval 85.3 to 91.7
|
88.7 Percentage of participants
Interval 85.5 to 91.9
|
—
|
—
|
|
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
|
92.1 Percentage of participants
Interval 89.4 to 94.8
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
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 8
|
92.1 Percentage of participants
Interval 89.4 to 94.8
|
94.8 Percentage of participants
Interval 92.5 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 12
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
92.6 Percentage of participants
Interval 89.9 to 95.2
|
—
|
—
|
|
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 16
|
92.6 Percentage of participants
Interval 90.0 to 95.3
|
92.0 Percentage of participants
Interval 89.3 to 94.8
|
—
|
—
|
|
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 20
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
91.4 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
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
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
89.2 Percentage of participants
Interval 86.1 to 92.4
|
—
|
—
|
|
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
|
88.0 Percentage of participants
Interval 84.7 to 91.3
|
88.4 Percentage of participants
Interval 85.2 to 91.7
|
—
|
—
|
|
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 32
|
89.4 Percentage of participants
Interval 86.2 to 92.5
|
92.0 Percentage of participants
Interval 89.2 to 94.8
|
—
|
—
|
|
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 36
|
89.9 Percentage of participants
Interval 86.9 to 93.0
|
90.1 Percentage of participants
Interval 87.0 to 93.1
|
—
|
—
|
|
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 40
|
87.7 Percentage of participants
Interval 84.5 to 91.0
|
88.7 Percentage of participants
Interval 85.5 to 91.9
|
—
|
—
|
|
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
|
88.5 Percentage of participants
Interval 85.3 to 91.7
|
89.2 Percentage of participants
Interval 86.1 to 92.4
|
—
|
—
|
|
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
|
85.8 Percentage of participants
Interval 82.2 to 89.3
|
89.0 Percentage of participants
Interval 85.8 to 92.2
|
—
|
—
|
|
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
|
85.8 Percentage of participants
Interval 82.3 to 89.3
|
87.3 Percentage of participants
Interval 83.9 to 90.7
|
—
|
—
|
|
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 60
|
86.6 Percentage of participants
Interval 83.2 to 90.0
|
87.3 Percentage of participants
Interval 83.9 to 90.7
|
—
|
—
|
|
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 64
|
86.1 Percentage of participants
Interval 82.6 to 89.6
|
86.2 Percentage of participants
Interval 82.7 to 89.7
|
—
|
—
|
|
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 68
|
87.4 Percentage of participants
Interval 84.1 to 90.8
|
85.4 Percentage of participants
Interval 81.8 to 89.0
|
—
|
—
|
|
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 72
|
86.6 Percentage of participants
Interval 83.2 to 90.1
|
85.7 Percentage of participants
Interval 82.1 to 89.2
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
97.3 Percentage of participants
Interval 95.6 to 98.9
|
97.0 Percentage of participants
Interval 95.2 to 98.7
|
—
|
—
|
|
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
|
96.2 Percentage of participants
Interval 94.3 to 98.1
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
—
|
—
|
|
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 48
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
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
|
93.5 Percentage of participants
Interval 91.0 to 96.0
|
95.3 Percentage of participants
Interval 93.2 to 97.5
|
—
|
—
|
|
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 4
|
98.4 Percentage of participants
Interval 97.1 to 99.7
|
98.9 Percentage of participants
Interval 97.8 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
|
98.1 Percentage of participants
Interval 96.7 to 99.5
|
98.1 Percentage of participants
Interval 96.7 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 12
|
98.6 Percentage of participants
Interval 97.5 to 99.8
|
97.5 Percentage of participants
Interval 95.9 to 99.1
|
—
|
—
|
|
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
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
—
|
—
|
|
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 28
|
95.6 Percentage of participants
Interval 93.6 to 97.7
|
94.2 Percentage of participants
Interval 91.8 to 96.6
|
—
|
—
|
|
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
|
95.4 Percentage of participants
Interval 93.3 to 97.5
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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
|
95.4 Percentage of participants
Interval 93.3 to 97.5
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 40
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 44
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
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
|
94.6 Percentage of participants
Interval 92.3 to 96.8
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
—
|
—
|
|
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 56
|
95.1 Percentage of participants
Interval 92.9 to 97.3
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
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
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
94.8 Percentage of participants
Interval 92.5 to 97.0
|
—
|
—
|
|
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 68
|
93.5 Percentage of participants
Interval 90.9 to 96.0
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 72
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
95.0 Percentage of participants
Interval 92.8 to 97.2
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 8
|
97.5 Percentage of participants
Interval 96.0 to 99.1
|
97.5 Percentage of participants
Interval 95.9 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 28
|
94.6 Percentage of participants
Interval 92.3 to 96.9
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
—
|
—
|
|
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 52
|
92.9 Percentage of participants
Interval 90.3 to 95.5
|
95.0 Percentage of participants
Interval 92.8 to 97.2
|
—
|
—
|
|
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
|
92.1 Percentage of participants
Interval 89.4 to 94.8
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
—
|
—
|
|
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 68
|
92.6 Percentage of participants
Interval 90.0 to 95.3
|
94.2 Percentage of participants
Interval 91.8 to 96.6
|
—
|
—
|
|
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
|
98.1 Percentage of participants
Interval 96.7 to 99.5
|
98.6 Percentage of participants
Interval 97.4 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 12
|
97.8 Percentage of participants
Interval 96.3 to 99.3
|
97.0 Percentage of participants
Interval 95.2 to 98.7
|
—
|
—
|
|
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 16
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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 20
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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 24
|
95.1 Percentage of participants
Interval 92.9 to 97.3
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 32
|
94.3 Percentage of participants
Interval 91.9 to 96.6
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
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 36
|
94.3 Percentage of participants
Interval 91.9 to 96.6
|
95.0 Percentage of participants
Interval 92.8 to 97.3
|
—
|
—
|
|
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
|
92.9 Percentage of participants
Interval 90.3 to 95.5
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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
|
93.2 Percentage of participants
Interval 90.7 to 95.7
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
—
|
—
|
|
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
|
92.4 Percentage of participants
Interval 89.7 to 95.0
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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
|
91.3 Percentage of participants
Interval 88.4 to 94.1
|
93.6 Percentage of participants
Interval 91.2 to 96.1
|
—
|
—
|
|
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 64
|
92.9 Percentage of participants
Interval 90.3 to 95.5
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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
|
92.6 Percentage of participants
Interval 90.0 to 95.3
|
93.7 Percentage of participants
Interval 91.2 to 96.1
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
95.4 Percentage of participants
Interval 93.2 to 97.5
|
94.8 Percentage of participants
Interval 92.5 to 97.0
|
—
|
—
|
|
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 28
|
92.4 Percentage of participants
Interval 89.7 to 95.1
|
91.7 Percentage of participants
Interval 88.9 to 94.5
|
—
|
—
|
|
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
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
—
|
—
|
|
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 68
|
89.6 Percentage of participants
Interval 86.6 to 92.7
|
91.7 Percentage of participants
Interval 88.9 to 94.5
|
—
|
—
|
|
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 72
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
90.6 Percentage of participants
Interval 87.7 to 93.6
|
—
|
—
|
|
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
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
98.1 Percentage of participants
Interval 96.7 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 8
|
96.2 Percentage of participants
Interval 94.2 to 98.1
|
96.4 Percentage of participants
Interval 94.5 to 98.3
|
—
|
—
|
|
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 12
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
96.1 Percentage of participants
Interval 94.2 to 98.1
|
—
|
—
|
|
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 20
|
94.8 Percentage of participants
Interval 92.6 to 97.1
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
93.7 Percentage of participants
Interval 91.2 to 96.1
|
—
|
—
|
|
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 32
|
91.3 Percentage of participants
Interval 88.4 to 94.1
|
94.8 Percentage of participants
Interval 92.5 to 97.0
|
—
|
—
|
|
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 36
|
92.7 Percentage of participants
Interval 90.0 to 95.3
|
94.2 Percentage of participants
Interval 91.8 to 96.6
|
—
|
—
|
|
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
|
91.0 Percentage of participants
Interval 88.1 to 93.9
|
92.6 Percentage of participants
Interval 89.9 to 95.2
|
—
|
—
|
|
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
|
90.7 Percentage of participants
Interval 87.8 to 93.6
|
92.8 Percentage of participants
Interval 90.2 to 95.4
|
—
|
—
|
|
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
|
91.0 Percentage of participants
Interval 88.1 to 93.9
|
92.6 Percentage of participants
Interval 89.9 to 95.2
|
—
|
—
|
|
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
|
88.5 Percentage of participants
Interval 85.3 to 91.7
|
91.4 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
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
|
90.5 Percentage of participants
Interval 87.5 to 93.4
|
92.3 Percentage of participants
Interval 89.6 to 95.0
|
—
|
—
|
|
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 64
|
90.7 Percentage of participants
Interval 87.8 to 93.7
|
91.2 Percentage of participants
Interval 88.3 to 94.1
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
6.0 Percentage of participants
Interval 3.6 to 8.4
|
4.7 Percentage of participants
Interval 2.6 to 6.8
|
—
|
—
|
|
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 16
|
11.5 Percentage of participants
Interval 8.4 to 14.6
|
14.1 Percentage of participants
Interval 10.7 to 17.5
|
—
|
—
|
|
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
|
14.2 Percentage of participants
Interval 10.9 to 17.6
|
14.9 Percentage of participants
Interval 11.4 to 18.3
|
—
|
—
|
|
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 28
|
9.8 Percentage of participants
Interval 6.9 to 12.8
|
12.7 Percentage of participants
Interval 9.5 to 15.9
|
—
|
—
|
|
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
|
16.7 Percentage of participants
Interval 13.0 to 20.3
|
14.9 Percentage of participants
Interval 11.4 to 18.4
|
—
|
—
|
|
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
|
14.8 Percentage of participants
Interval 11.3 to 18.2
|
15.5 Percentage of participants
Interval 12.0 to 18.9
|
—
|
—
|
|
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
|
15.8 Percentage of participants
Interval 12.3 to 19.4
|
16.3 Percentage of participants
Interval 12.7 to 19.9
|
—
|
—
|
|
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
|
16.1 Percentage of participants
Interval 12.5 to 19.8
|
15.7 Percentage of participants
Interval 12.2 to 19.3
|
—
|
—
|
|
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 72
|
15.3 Percentage of participants
Interval 11.8 to 18.8
|
14.4 Percentage of participants
Interval 11.0 to 17.7
|
—
|
—
|
|
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 68
|
15.3 Percentage of participants
Interval 11.8 to 18.9
|
15.2 Percentage of participants
Interval 11.7 to 18.7
|
—
|
—
|
|
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 8
|
8.7 Percentage of participants
Interval 5.9 to 11.5
|
10.2 Percentage of participants
Interval 7.2 to 13.2
|
—
|
—
|
|
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
|
10.9 Percentage of participants
Interval 7.8 to 14.0
|
11.9 Percentage of participants
Interval 8.7 to 15.0
|
—
|
—
|
|
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 24
|
14.5 Percentage of participants
Interval 11.0 to 17.9
|
15.2 Percentage of participants
Interval 11.7 to 18.7
|
—
|
—
|
|
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 32
|
13.4 Percentage of participants
Interval 10.0 to 16.7
|
14.9 Percentage of participants
Interval 11.4 to 18.3
|
—
|
—
|
|
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 36
|
15.3 Percentage of participants
Interval 11.8 to 18.8
|
14.9 Percentage of participants
Interval 11.5 to 18.3
|
—
|
—
|
|
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 40
|
14.8 Percentage of participants
Interval 11.3 to 18.2
|
12.4 Percentage of participants
Interval 9.2 to 15.7
|
—
|
—
|
|
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 44
|
15.5 Percentage of participants
Interval 12.0 to 19.1
|
14.1 Percentage of participants
Interval 10.7 to 17.5
|
—
|
—
|
|
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 48
|
15.0 Percentage of participants
Interval 11.6 to 18.5
|
14.6 Percentage of participants
Interval 11.2 to 18.0
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
45.0 Percentage of participants
Interval 41.0 to 49.1
|
46.1 Percentage of participants
Interval 41.9 to 50.2
|
—
|
—
|
|
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
|
48.6 Percentage of participants
Interval 44.3 to 52.8
|
54.6 Percentage of participants
Interval 50.5 to 58.7
|
—
|
—
|
|
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 12
|
54.9 Percentage of participants
Interval 50.8 to 58.9
|
55.7 Percentage of participants
Interval 51.4 to 60.0
|
—
|
—
|
|
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 24
|
55.7 Percentage of participants
Interval 51.3 to 60.0
|
59.0 Percentage of participants
Interval 54.5 to 63.4
|
—
|
—
|
|
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
|
56.2 Percentage of participants
Interval 51.8 to 60.7
|
60.6 Percentage of participants
Interval 56.2 to 65.1
|
—
|
—
|
|
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 52
|
54.3 Percentage of participants
Interval 49.8 to 58.9
|
60.4 Percentage of participants
Interval 55.9 to 64.8
|
—
|
—
|
|
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 60
|
56.0 Percentage of participants
Interval 51.5 to 60.4
|
58.7 Percentage of participants
Interval 54.3 to 63.1
|
—
|
—
|
|
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 16
|
54.9 Percentage of participants
Interval 50.6 to 59.1
|
59.3 Percentage of participants
Interval 55.2 to 63.4
|
—
|
—
|
|
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
|
54.1 Percentage of participants
Interval 49.7 to 58.4
|
57.6 Percentage of participants
Interval 53.4 to 61.8
|
—
|
—
|
|
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 28
|
53.2 Percentage of participants
Interval 48.8 to 57.7
|
56.2 Percentage of participants
Interval 51.8 to 60.7
|
—
|
—
|
|
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 32
|
56.0 Percentage of participants
Interval 51.6 to 60.4
|
60.4 Percentage of participants
Interval 56.1 to 64.6
|
—
|
—
|
|
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
|
53.8 Percentage of participants
Interval 49.4 to 58.2
|
60.7 Percentage of participants
Interval 56.3 to 65.0
|
—
|
—
|
|
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 40
|
51.9 Percentage of participants
Interval 47.3 to 56.4
|
56.2 Percentage of participants
Interval 51.7 to 60.8
|
—
|
—
|
|
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 44
|
53.0 Percentage of participants
Interval 48.4 to 57.6
|
60.9 Percentage of participants
Interval 56.5 to 65.3
|
—
|
—
|
|
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 56
|
51.9 Percentage of participants
Interval 47.3 to 56.4
|
58.7 Percentage of participants
Interval 54.3 to 63.2
|
—
|
—
|
|
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
|
56.5 Percentage of participants
Interval 52.1 to 61.0
|
57.9 Percentage of participants
Interval 53.4 to 62.4
|
—
|
—
|
|
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
|
56.0 Percentage of participants
Interval 51.5 to 60.4
|
57.9 Percentage of participants
Interval 53.4 to 62.4
|
—
|
—
|
|
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
|
56.2 Percentage of participants
Interval 51.7 to 60.8
|
58.5 Percentage of participants
Interval 53.9 to 63.1
|
—
|
—
|
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 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 16
|
7.8 Percentage of participants
Interval 5.3 to 10.4
|
6.2 Percentage of participants
Interval 3.8 to 8.5
|
—
|
—
|
|
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
|
11.4 Percentage of participants
Interval 8.3 to 14.5
|
8.3 Percentage of participants
Interval 5.7 to 11.0
|
—
|
—
|
|
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
|
11.1 Percentage of participants
Interval 8.0 to 14.2
|
8.3 Percentage of participants
Interval 5.6 to 11.0
|
—
|
—
|
|
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
|
10.0 Percentage of participants
Interval 7.3 to 12.8
|
8.6 Percentage of participants
Interval 6.1 to 11.1
|
—
|
—
|
|
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
|
8.2 Percentage of participants
Interval 5.5 to 10.8
|
7.0 Percentage of participants
Interval 4.6 to 9.4
|
—
|
—
|
|
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
|
7.3 Percentage of participants
Interval 4.9 to 9.8
|
6.4 Percentage of participants
Interval 4.0 to 8.8
|
—
|
—
|
|
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 20
|
8.4 Percentage of participants
Interval 5.7 to 11.0
|
6.4 Percentage of participants
Interval 4.0 to 8.8
|
—
|
—
|
|
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 24
|
10.1 Percentage of participants
Interval 7.1 to 13.0
|
7.5 Percentage of participants
Interval 4.9 to 10.1
|
—
|
—
|
|
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
|
8.9 Percentage of participants
Interval 6.1 to 11.7
|
9.4 Percentage of participants
Interval 6.6 to 12.3
|
—
|
—
|
|
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
|
9.2 Percentage of participants
Interval 6.4 to 12.0
|
8.0 Percentage of participants
Interval 5.4 to 10.7
|
—
|
—
|
|
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
|
9.5 Percentage of participants
Interval 6.6 to 12.4
|
8.3 Percentage of participants
Interval 5.7 to 11.0
|
—
|
—
|
|
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
|
9.8 Percentage of participants
Interval 6.8 to 12.7
|
7.5 Percentage of participants
Interval 4.9 to 10.1
|
—
|
—
|
|
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
|
10.6 Percentage of participants
Interval 7.5 to 13.6
|
8.3 Percentage of participants
Interval 5.6 to 11.0
|
—
|
—
|
|
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
|
10.0 Percentage of participants
Interval 7.1 to 13.0
|
7.5 Percentage of participants
Interval 4.9 to 10.1
|
—
|
—
|
|
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
|
11.4 Percentage of participants
Interval 8.3 to 14.5
|
7.2 Percentage of participants
Interval 4.7 to 9.8
|
—
|
—
|
|
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 56
|
11.9 Percentage of participants
Interval 8.8 to 15.1
|
8.6 Percentage of participants
Interval 5.8 to 11.4
|
—
|
—
|
|
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
|
11.2 Percentage of participants
Interval 8.0 to 14.3
|
8.3 Percentage of participants
Interval 5.6 to 11.0
|
—
|
—
|
|
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
|
11.4 Percentage of participants
Interval 8.3 to 14.6
|
8.0 Percentage of participants
Interval 5.4 to 10.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 24
|
7.0 score on a scale
Interval 5.9 to 8.0
|
8.2 score on a scale
Interval 7.1 to 9.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Week 48
|
7.0 score on a scale
Interval 5.9 to 8.2
|
8.3 score on a scale
Interval 7.1 to 9.5
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Week 72
|
7.8 score on a scale
Interval 6.5 to 9.0
|
8.5 score on a scale
Interval 7.3 to 9.8
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
-422.1 microns
Interval -430.6 to -413.7
|
-418.2 microns
Interval -426.6 to -409.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
-445.1 microns
Interval -453.6 to -436.6
|
-438.5 microns
Interval -447.0 to -429.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
-452.3 microns
Interval -461.8 to -442.8
|
-443.7 microns
Interval -453.2 to -434.1
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
-453.8 microns
Interval -463.1 to -444.5
|
-446.2 microns
Interval -455.5 to -436.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
-460.0 microns
Interval -468.1 to -451.8
|
-447.1 microns
Interval -455.4 to -438.9
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
-462.3 microns
Interval -472.3 to -452.3
|
-447.8 microns
Interval -457.9 to -437.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
-415.5 microns
Interval -431.8 to -399.1
|
-413.7 microns
Interval -430.3 to -397.2
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
-459.4 microns
Interval -468.7 to -450.1
|
-445.8 microns
Interval -455.3 to -436.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
-451.7 microns
Interval -462.7 to -440.8
|
-441.8 microns
Interval -452.9 to -430.8
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
-409.8 microns
Interval -425.6 to -394.0
|
-414.0 microns
Interval -429.9 to -398.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
-456.6 microns
Interval -467.1 to -446.0
|
-449.8 microns
Interval -460.6 to -439.0
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
-461.2 microns
Interval -471.3 to -451.1
|
-448.0 microns
Interval -458.3 to -437.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
-446.0 microns
Interval -457.0 to -435.0
|
-451.8 microns
Interval -462.9 to -440.7
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
-435.9 microns
Interval -449.8 to -422.0
|
-426.2 microns
Interval -440.3 to -412.1
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
-468.2 microns
Interval -476.8 to -459.5
|
-458.9 microns
Interval -467.6 to -450.1
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
-466.6 microns
Interval -473.7 to -459.5
|
-465.5 microns
Interval -472.6 to -458.3
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
-467.5 microns
Interval -476.0 to -459.1
|
-457.7 microns
Interval -466.2 to -449.2
|
—
|
—
|
|
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
-463.5 microns
Interval -472.8 to -454.3
|
-458.6 microns
Interval -467.9 to -449.2
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
83.8 Percentage of participants
Interval 80.2 to 87.5
|
82.4 Percentage of participants
Interval 78.5 to 86.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
92.6 Percentage of participants
Interval 90.0 to 95.2
|
91.2 Percentage of participants
Interval 88.3 to 94.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
91.5 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
92.8 Percentage of participants
Interval 90.2 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 20
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
93.1 Percentage of participants
Interval 90.5 to 95.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
93.7 Percentage of participants
Interval 91.2 to 96.2
|
91.7 Percentage of participants
Interval 88.9 to 94.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
82.5 Percentage of participants
Interval 78.6 to 86.4
|
84.0 Percentage of participants
Interval 80.3 to 87.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
90.3 Percentage of participants
Interval 87.4 to 93.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
91.8 Percentage of participants
Interval 89.0 to 94.6
|
89.5 Percentage of participants
Interval 86.4 to 92.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
80.0 Percentage of participants
Interval 76.0 to 84.1
|
80.7 Percentage of participants
Interval 76.7 to 84.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
90.9 Percentage of participants
Interval 88.0 to 93.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
92.6 Percentage of participants
Interval 89.9 to 95.3
|
89.8 Percentage of participants
Interval 86.7 to 92.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
88.5 Percentage of participants
Interval 85.2 to 91.8
|
90.9 Percentage of participants
Interval 88.0 to 93.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
87.4 Percentage of participants
Interval 84.1 to 90.8
|
84.3 Percentage of participants
Interval 80.6 to 88.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
93.7 Percentage of participants
Interval 91.3 to 96.2
|
92.8 Percentage of participants
Interval 90.2 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 64
|
94.3 Percentage of participants
Interval 91.9 to 96.6
|
93.4 Percentage of participants
Interval 90.8 to 95.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
93.2 Percentage of participants
Interval 90.6 to 95.7
|
91.4 Percentage of participants
Interval 88.6 to 94.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
92.4 Percentage of participants
Interval 89.6 to 95.1
|
91.2 Percentage of participants
Interval 88.3 to 94.0
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 64
|
76.5 Percentage of participants
Interval 72.2 to 80.8
|
72.7 Percentage of participants
Interval 68.2 to 77.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
78.1 Percentage of participants
Interval 73.9 to 82.3
|
74.4 Percentage of participants
Interval 69.9 to 78.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
66.9 Percentage of participants
Interval 62.2 to 71.6
|
63.4 Percentage of participants
Interval 58.5 to 68.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
60.9 Percentage of participants
Interval 56.0 to 65.9
|
58.7 Percentage of participants
Interval 53.7 to 63.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
71.6 Percentage of participants
Interval 67.0 to 76.1
|
72.7 Percentage of participants
Interval 68.2 to 77.2
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 4
|
45.5 Percentage of participants
Interval 40.6 to 50.5
|
40.6 Percentage of participants
Interval 35.8 to 45.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
63.1 Percentage of participants
Interval 58.3 to 68.0
|
61.7 Percentage of participants
Interval 56.9 to 66.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
53.2 Percentage of participants
Interval 48.3 to 58.2
|
51.0 Percentage of participants
Interval 46.2 to 55.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 16
|
55.4 Percentage of participants
Interval 50.5 to 60.3
|
51.9 Percentage of participants
Interval 46.8 to 56.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
59.0 Percentage of participants
Interval 54.0 to 63.9
|
56.5 Percentage of participants
Interval 51.6 to 61.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
77.0 Percentage of participants
Interval 72.8 to 81.3
|
70.8 Percentage of participants
Interval 66.2 to 75.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
53.8 Percentage of participants
Interval 48.7 to 58.9
|
51.5 Percentage of participants
Interval 46.4 to 56.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
67.7 Percentage of participants
Interval 63.1 to 72.4
|
67.2 Percentage of participants
Interval 62.5 to 72.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
62.8 Percentage of participants
Interval 58.1 to 67.5
|
57.6 Percentage of participants
Interval 52.6 to 62.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
52.7 Percentage of participants
Interval 47.7 to 57.7
|
51.0 Percentage of participants
Interval 46.0 to 56.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
66.4 Percentage of participants
Interval 61.6 to 71.2
|
63.4 Percentage of participants
Interval 58.5 to 68.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
74.3 Percentage of participants
Interval 69.9 to 78.8
|
69.7 Percentage of participants
Interval 65.0 to 74.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
74.6 Percentage of participants
Interval 70.2 to 79.0
|
71.3 Percentage of participants
Interval 66.8 to 75.9
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
66.1 Percentage of participants
Interval 61.4 to 70.8
|
65.0 Percentage of participants
Interval 60.3 to 69.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 8
|
89.6 Percentage of participants
Interval 86.5 to 92.6
|
90.1 Percentage of participants
Interval 87.0 to 93.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
97.6 Percentage of participants
Interval 96.0 to 99.1
|
93.9 Percentage of participants
Interval 91.6 to 96.3
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 12
|
94.0 Percentage of participants
Interval 91.6 to 96.4
|
93.9 Percentage of participants
Interval 91.5 to 96.4
|
—
|
—
|
|
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 93.2 to 97.5
|
95.6 Percentage of participants
Interval 93.5 to 97.7
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 20
|
95.9 Percentage of participants
Interval 93.9 to 97.9
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 24
|
96.2 Percentage of participants
Interval 94.2 to 98.1
|
93.4 Percentage of participants
Interval 90.8 to 95.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 28
|
89.3 Percentage of participants
Interval 86.2 to 92.5
|
90.1 Percentage of participants
Interval 87.0 to 93.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
95.6 Percentage of participants
Interval 93.6 to 97.7
|
94.5 Percentage of participants
Interval 92.2 to 96.8
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
95.1 Percentage of participants
Interval 92.9 to 97.3
|
92.3 Percentage of participants
Interval 89.6 to 95.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
89.6 Percentage of participants
Interval 86.5 to 92.7
|
89.3 Percentage of participants
Interval 86.1 to 92.4
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
95.4 Percentage of participants
Interval 93.2 to 97.5
|
92.8 Percentage of participants
Interval 90.2 to 95.5
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
89.5 Percentage of participants
Interval 86.4 to 92.6
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
92.6 Percentage of participants
Interval 89.9 to 95.3
|
93.6 Percentage of participants
Interval 91.2 to 96.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
93.4 Percentage of participants
Interval 90.9 to 95.9
|
90.1 Percentage of participants
Interval 87.1 to 93.1
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
94.8 Percentage of participants
Interval 92.5 to 97.0
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
96.7 Percentage of participants
Interval 94.9 to 98.5
|
95.9 Percentage of participants
Interval 93.8 to 97.9
|
—
|
—
|
|
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
95.4 Percentage of participants
Interval 93.2 to 97.5
|
93.1 Percentage of participants
Interval 90.6 to 95.7
|
—
|
—
|
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.
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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 72
|
77.0 Percentage of participants
Interval 72.8 to 81.3
|
71.6 Percentage of participants
Interval 67.0 to 76.3
|
—
|
—
|
|
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
|
52.7 Percentage of participants
Interval 47.7 to 57.6
|
50.2 Percentage of participants
Interval 45.3 to 55.1
|
—
|
—
|
|
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 44
|
64.7 Percentage of participants
Interval 59.9 to 69.6
|
60.9 Percentage of participants
Interval 56.0 to 65.8
|
—
|
—
|
|
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 52
|
65.8 Percentage of participants
Interval 61.1 to 70.6
|
61.7 Percentage of participants
Interval 56.8 to 66.6
|
—
|
—
|
|
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 4
|
33.0 Percentage of participants
Interval 28.3 to 37.6
|
29.3 Percentage of participants
Interval 24.9 to 33.7
|
—
|
—
|
|
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 8
|
59.3 Percentage of participants
Interval 54.4 to 64.1
|
59.3 Percentage of participants
Interval 54.3 to 64.2
|
—
|
—
|
|
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 16
|
54.9 Percentage of participants
Interval 49.9 to 59.8
|
51.3 Percentage of participants
Interval 46.3 to 56.3
|
—
|
—
|
|
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
|
58.2 Percentage of participants
Interval 53.2 to 63.1
|
55.4 Percentage of participants
Interval 50.5 to 60.4
|
—
|
—
|
|
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 24
|
76.0 Percentage of participants
Interval 71.6 to 80.3
|
68.6 Percentage of participants
Interval 63.8 to 73.4
|
—
|
—
|
|
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 28
|
52.7 Percentage of participants
Interval 47.6 to 57.8
|
51.2 Percentage of participants
Interval 46.1 to 56.3
|
—
|
—
|
|
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
|
67.2 Percentage of participants
Interval 62.6 to 71.8
|
66.4 Percentage of participants
Interval 61.6 to 71.2
|
—
|
—
|
|
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
|
62.8 Percentage of participants
Interval 58.1 to 67.5
|
56.5 Percentage of participants
Interval 51.5 to 61.5
|
—
|
—
|
|
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
|
52.7 Percentage of participants
Interval 47.7 to 57.7
|
50.2 Percentage of participants
Interval 45.1 to 55.2
|
—
|
—
|
|
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
|
70.8 Percentage of participants
Interval 66.1 to 75.4
|
65.8 Percentage of participants
Interval 61.0 to 70.6
|
—
|
—
|
|
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 56
|
60.7 Percentage of participants
Interval 55.7 to 65.6
|
58.1 Percentage of participants
Interval 53.2 to 63.0
|
—
|
—
|
|
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
|
71.0 Percentage of participants
Interval 66.4 to 75.6
|
71.6 Percentage of participants
Interval 67.0 to 76.2
|
—
|
—
|
|
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 64
|
75.4 Percentage of participants
Interval 71.1 to 79.8
|
71.9 Percentage of participants
Interval 67.3 to 76.4
|
—
|
—
|
|
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 68
|
74.3 Percentage of participants
Interval 69.9 to 78.8
|
70.8 Percentage of participants
Interval 66.2 to 75.3
|
—
|
—
|
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. 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\] 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=340 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=331 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
-0.8 ETDRS Letters
Interval -1.6 to 0.0
|
-1.2 ETDRS Letters
Interval -2.0 to -0.4
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 32
|
0.2 ETDRS Letters
Interval -0.6 to 0.9
|
0.2 ETDRS Letters
Interval -0.6 to 1.0
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 36
|
-0.1 ETDRS Letters
Interval -0.8 to 0.7
|
0.1 ETDRS Letters
Interval -0.7 to 0.9
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 40
|
-1.3 ETDRS Letters
Interval -2.4 to -0.2
|
-1.4 ETDRS Letters
Interval -2.4 to -0.3
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 44
|
-0.6 ETDRS Letters
Interval -1.6 to 0.4
|
0.0 ETDRS Letters
Interval -1.0 to 1.0
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 48
|
-0.1 ETDRS Letters
Interval -1.1 to 0.9
|
0.2 ETDRS Letters
Interval -0.8 to 1.1
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 52
|
-0.6 ETDRS Letters
Interval -1.6 to 0.4
|
0.3 ETDRS Letters
Interval -0.6 to 1.3
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 56
|
-1.1 ETDRS Letters
Interval -2.1 to 0.0
|
-0.6 ETDRS Letters
Interval -1.7 to 0.5
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 60
|
0.0 ETDRS Letters
Interval -1.1 to 1.0
|
-0.1 ETDRS Letters
Interval -1.2 to 0.9
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 64
|
-0.2 ETDRS Letters
Interval -1.3 to 0.8
|
-0.2 ETDRS Letters
Interval -1.3 to 0.9
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 68
|
-0.1 ETDRS Letters
Interval -1.2 to 1.0
|
-0.5 ETDRS Letters
Interval -1.6 to 0.6
|
—
|
—
|
|
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
Week 72
|
-0.2 ETDRS Letters
Interval -1.3 to 1.0
|
-0.3 ETDRS Letters
Interval -1.5 to 0.8
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
86.3 Percentage of participants
Interval 82.9 to 89.8
|
83.8 Percentage of participants
Interval 80.0 to 87.5
|
—
|
—
|
|
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 32
|
88.8 Percentage of participants
Interval 85.6 to 92.0
|
87.9 Percentage of participants
Interval 84.6 to 91.2
|
—
|
—
|
|
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 36
|
89.3 Percentage of participants
Interval 86.2 to 92.5
|
87.9 Percentage of participants
Interval 84.6 to 91.2
|
—
|
—
|
|
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
|
87.4 Percentage of participants
Interval 84.0 to 90.8
|
86.0 Percentage of participants
Interval 82.4 to 89.5
|
—
|
—
|
|
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 44
|
87.4 Percentage of participants
Interval 84.0 to 90.8
|
88.4 Percentage of participants
Interval 85.2 to 91.7
|
—
|
—
|
|
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
|
88.5 Percentage of participants
Interval 85.3 to 91.7
|
87.3 Percentage of participants
Interval 83.9 to 90.7
|
—
|
—
|
|
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
|
86.3 Percentage of participants
Interval 82.8 to 89.8
|
87.6 Percentage of participants
Interval 84.2 to 91.0
|
—
|
—
|
|
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
|
85.7 Percentage of participants
Interval 82.2 to 89.3
|
85.4 Percentage of participants
Interval 81.8 to 89.0
|
—
|
—
|
|
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
|
87.7 Percentage of participants
Interval 84.3 to 91.0
|
86.2 Percentage of participants
Interval 82.7 to 89.8
|
—
|
—
|
|
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 64
|
86.3 Percentage of participants
Interval 82.8 to 89.8
|
85.9 Percentage of participants
Interval 82.4 to 89.5
|
—
|
—
|
|
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 68
|
87.1 Percentage of participants
Interval 83.7 to 90.5
|
85.4 Percentage of participants
Interval 81.8 to 89.0
|
—
|
—
|
|
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
|
86.6 Percentage of participants
Interval 83.1 to 90.0
|
84.0 Percentage of participants
Interval 80.3 to 87.8
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
82.8 Percentage of participants
Interval 79.0 to 86.6
|
81.3 Percentage of participants
Interval 77.3 to 85.2
|
—
|
—
|
|
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
|
87.1 Percentage of participants
Interval 83.7 to 90.6
|
86.0 Percentage of participants
Interval 82.4 to 89.5
|
—
|
—
|
|
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
|
84.7 Percentage of participants
Interval 81.0 to 88.4
|
85.4 Percentage of participants
Interval 81.8 to 89.0
|
—
|
—
|
|
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
|
82.8 Percentage of participants
Interval 78.9 to 86.6
|
81.6 Percentage of participants
Interval 77.6 to 85.5
|
—
|
—
|
|
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
|
84.1 Percentage of participants
Interval 80.4 to 87.9
|
86.8 Percentage of participants
Interval 83.4 to 90.2
|
—
|
—
|
|
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
|
84.4 Percentage of participants
Interval 80.7 to 88.1
|
84.8 Percentage of participants
Interval 81.2 to 88.5
|
—
|
—
|
|
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
|
82.8 Percentage of participants
Interval 78.9 to 86.6
|
85.4 Percentage of participants
Interval 81.8 to 89.0
|
—
|
—
|
|
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
|
80.0 Percentage of participants
Interval 76.0 to 84.1
|
81.8 Percentage of participants
Interval 77.9 to 85.8
|
—
|
—
|
|
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
|
83.6 Percentage of participants
Interval 79.8 to 87.4
|
82.6 Percentage of participants
Interval 78.8 to 86.5
|
—
|
—
|
|
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
|
81.7 Percentage of participants
Interval 77.7 to 85.6
|
83.2 Percentage of participants
Interval 79.4 to 87.0
|
—
|
—
|
|
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
|
82.2 Percentage of participants
Interval 78.3 to 86.1
|
80.7 Percentage of participants
Interval 76.7 to 84.7
|
—
|
—
|
|
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
|
82.5 Percentage of participants
Interval 78.6 to 86.3
|
80.7 Percentage of participants
Interval 76.7 to 84.7
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
72.7 Percentage of participants
Interval 68.2 to 77.2
|
69.7 Percentage of participants
Interval 65.0 to 74.4
|
—
|
—
|
|
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
|
78.4 Percentage of participants
Interval 74.2 to 82.6
|
75.5 Percentage of participants
Interval 71.1 to 79.9
|
—
|
—
|
|
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 36
|
74.1 Percentage of participants
Interval 69.6 to 78.5
|
80.2 Percentage of participants
Interval 76.1 to 84.2
|
—
|
—
|
|
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
|
71.0 Percentage of participants
Interval 66.4 to 75.6
|
71.6 Percentage of participants
Interval 67.0 to 76.2
|
—
|
—
|
|
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
|
73.7 Percentage of participants
Interval 69.3 to 78.2
|
73.0 Percentage of participants
Interval 68.5 to 77.6
|
—
|
—
|
|
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
|
76.5 Percentage of participants
Interval 72.2 to 80.8
|
74.1 Percentage of participants
Interval 69.6 to 78.6
|
—
|
—
|
|
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
|
71.3 Percentage of participants
Interval 66.7 to 75.9
|
74.1 Percentage of participants
Interval 69.6 to 78.6
|
—
|
—
|
|
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
|
69.4 Percentage of participants
Interval 64.7 to 74.1
|
68.3 Percentage of participants
Interval 63.6 to 73.1
|
—
|
—
|
|
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
|
74.3 Percentage of participants
Interval 69.8 to 78.7
|
71.6 Percentage of participants
Interval 67.0 to 76.2
|
—
|
—
|
|
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
|
74.6 Percentage of participants
Interval 70.1 to 79.0
|
71.6 Percentage of participants
Interval 67.0 to 76.2
|
—
|
—
|
|
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
|
73.2 Percentage of participants
Interval 68.7 to 77.7
|
69.2 Percentage of participants
Interval 64.5 to 73.8
|
—
|
—
|
|
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 72
|
72.9 Percentage of participants
Interval 68.4 to 77.5
|
70.3 Percentage of participants
Interval 65.6 to 74.9
|
—
|
—
|
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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. 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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=363 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
48.9 Percentage of participants
Interval 43.8 to 54.0
|
45.4 Percentage of participants
Interval 40.4 to 50.5
|
—
|
—
|
|
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 32
|
56.0 Percentage of participants
Interval 50.9 to 61.1
|
52.9 Percentage of participants
Interval 47.8 to 58.0
|
—
|
—
|
|
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
|
55.5 Percentage of participants
Interval 50.4 to 60.5
|
55.1 Percentage of participants
Interval 50.0 to 60.2
|
—
|
—
|
|
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 40
|
53.0 Percentage of participants
Interval 47.9 to 58.0
|
48.2 Percentage of participants
Interval 43.1 to 53.3
|
—
|
—
|
|
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 44
|
53.0 Percentage of participants
Interval 47.9 to 58.0
|
54.0 Percentage of participants
Interval 49.0 to 59.1
|
—
|
—
|
|
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 48
|
56.5 Percentage of participants
Interval 51.5 to 61.6
|
53.5 Percentage of participants
Interval 48.4 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 52
|
56.0 Percentage of participants
Interval 50.9 to 61.1
|
56.5 Percentage of participants
Interval 51.4 to 61.5
|
—
|
—
|
|
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 56
|
54.9 Percentage of participants
Interval 49.8 to 60.0
|
53.2 Percentage of participants
Interval 48.1 to 58.2
|
—
|
—
|
|
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
|
55.9 Percentage of participants
Interval 50.9 to 61.0
|
51.0 Percentage of participants
Interval 45.9 to 56.1
|
—
|
—
|
|
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 64
|
54.6 Percentage of participants
Interval 49.5 to 59.7
|
52.1 Percentage of participants
Interval 47.0 to 57.2
|
—
|
—
|
|
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 68
|
55.4 Percentage of participants
Interval 50.4 to 60.4
|
52.3 Percentage of participants
Interval 47.3 to 57.4
|
—
|
—
|
|
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 72
|
55.4 Percentage of participants
Interval 50.4 to 60.5
|
52.7 Percentage of participants
Interval 47.6 to 57.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 68Population: The analysis population included all randomized participants who had not discontinued the study at Week 68 and with available treatment interval information.
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=330 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=315 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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)
|
34.5 Percentage of participants
Interval 29.4 to 39.7
|
32.4 Percentage of participants
Interval 27.2 to 37.6
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 8 Weeks (Q8W)
|
20.0 Percentage of participants
Interval 15.7 to 24.3
|
17.5 Percentage of participants
Interval 13.3 to 21.7
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 12 Weeks (Q12W)
|
8.5 Percentage of participants
Interval 5.5 to 11.5
|
11.1 Percentage of participants
Interval 7.6 to 14.6
|
—
|
—
|
|
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Once Every 16 Weeks (Q16W)
|
37.0 Percentage of participants
Interval 31.8 to 42.2
|
39.0 Percentage of participants
Interval 33.7 to 44.4
|
—
|
—
|
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=359 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=342 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
5.0 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; in Arm B, all participants who received at least one faricimab dose.
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=365 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=361 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=359 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=342 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
Treatment Related AEs
|
15 Participants
|
6 Participants
|
14 Participants
|
11 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
|
3 Participants
|
2 Participants
|
4 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)
|
8 Participants
|
12 Participants
|
21 Participants
|
9 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
|
6 Participants
|
6 Participants
|
15 Participants
|
7 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
AESI: Associated with Severe IOI
|
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
AESI: Intervention Req. to Prevent Permanent Vision Loss
|
2 Participants
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
Adverse Event (AE)
|
89 Participants
|
98 Participants
|
130 Participants
|
118 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
|
65 Participants
|
65 Participants
|
63 Participants
|
69 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
|
18 Participants
|
27 Participants
|
52 Participants
|
43 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
|
6 Participants
|
6 Participants
|
15 Participants
|
6 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)
|
9 Participants
|
13 Participants
|
26 Participants
|
12 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
|
3 Participants
|
2 Participants
|
5 Participants
|
3 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; in Arm B, all participants who received at least one faricimab dose.
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=365 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=361 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=359 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=342 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)
|
31 Participants
|
33 Participants
|
70 Participants
|
51 Participants
|
|
Incidence of Ocular Adverse Events in the Fellow Eye
Serious Adverse Event (SAE)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Ocular Adverse Events in the Fellow Eye
Any AE of Special Interest (AESI)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Incidence of Ocular Adverse Events in the Fellow Eye
AESI: Drop in Visual Acuity Score ≥30
|
1 Participants
|
1 Participants
|
1 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; in Arm B, all participants who received at least one faricimab dose.
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=365 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=361 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=359 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=342 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
Adverse Event (AE)
|
123 Participants
|
134 Participants
|
191 Participants
|
174 Participants
|
|
Incidence of Non-Ocular Adverse Events
Serious Adverse Event (SAE)
|
22 Participants
|
23 Participants
|
30 Participants
|
41 Participants
|
|
Incidence of Non-Ocular Adverse Events
AE Leading to Withdrawal from Study Treatment
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Incidence of Non-Ocular Adverse Events
Any AE of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 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) was 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=365 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=342 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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
|
0.0001 microgram per millilitre (μg/mL)
Standard Deviation 0.0009
|
—
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 4
|
0.0222 microgram per millilitre (μg/mL)
Standard Deviation 0.0176
|
—
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 24
|
0.0257 microgram per millilitre (μg/mL)
Standard Deviation 0.0217
|
0.0005 microgram per millilitre (μg/mL)
Standard Deviation 0.0014
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 28
|
0.0055 microgram per millilitre (μg/mL)
Standard Deviation 0.0086
|
0.0026 microgram per millilitre (μg/mL)
Standard Deviation 0.0084
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 52
|
0.0089 microgram per millilitre (μg/mL)
Standard Deviation 0.0142
|
0.0090 microgram per millilitre (μg/mL)
Standard Deviation 0.0136
|
—
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 72
|
0.0087 microgram per millilitre (μg/mL)
Standard Deviation 0.0140
|
0.0099 microgram per millilitre (μg/mL)
Standard Deviation 0.0167
|
—
|
—
|
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=366 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=342 Participants
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=708 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
|
4 Participants
|
5 Participants
|
9 Participants
|
—
|
|
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
Post-BL: Total ADA-Positive
|
62 Participants
|
27 Participants
|
89 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
|
60 Participants
|
23 Participants
|
83 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
|
2 Participants
|
4 Participants
|
6 Participants
|
—
|
Adverse Events
Arm A: Faricimab Q4W (Part 1)
Serious events: 32 serious events
Other events: 67 other events
Deaths: 1 deaths
Arm B: Aflibercept Q4W (Part 1)
Serious events: 34 serious events
Other events: 66 other events
Deaths: 2 deaths
Arm A: Faricimab Q4W to Faricimab PTI (Part 2)
Serious events: 55 serious events
Other events: 109 other events
Deaths: 4 deaths
Arm B: Aflibercept Q4W to Faricimab PTI (Part 2)
Serious events: 51 serious events
Other events: 118 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=365 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=361 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=359 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=342 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
Acute myocardial infarction
|
0.27%
1/365 • 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.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.58%
2/342 • 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.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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.
|
0.56%
2/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.83%
3/361 • 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.
|
0.84%
3/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Cystoid macular oedema
|
0.55%
2/365 • 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.
|
0.55%
2/361 • 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.
|
1.4%
5/359 • 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.
|
0.29%
1/342 • 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Non-infectious endophthalmitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 artery embolism
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 artery occlusion
|
0.55%
2/365 • 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.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.58%
2/342 • 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 ischaemia
|
0.27%
1/365 • 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.
|
0.55%
2/361 • 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.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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 tear
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.55%
2/361 • 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.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Uveitis
|
0.55%
2/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Visual acuity reduced
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Duodenal bulb deformity
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Duodenitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Gastritis erosive
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Haematochezia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Inguinal hernia
|
0.55%
2/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Obstructive pancreatitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Peptic ulcer
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Bile duct stone
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Gallbladder disorder
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Hepatic steatosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.82%
3/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Endophthalmitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Gastroenteritis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Osteomyelitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Osteomyelitis acute
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Pneumonia
|
0.55%
2/365 • 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.
|
0.28%
1/361 • 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.
|
0.84%
3/359 • 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.
|
0.58%
2/342 • 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.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.58%
2/342 • 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.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Shunt occlusion
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Diabetic ketoacidosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Lumbar spinal stenosis
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Osteonecrosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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)
Bladder adenocarcinoma stage unspecified
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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)
Gastric cancer
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Altered state of consciousness
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.55%
2/365 • 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.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Peripheral sensorimotor neuropathy
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Transient ischaemic attack
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Calculus urinary
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Urethral stenosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 haemorrhage
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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.
|
0.28%
1/361 • 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.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Dyspnoea
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Pickwickian syndrome
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.27%
1/365 • 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.
|
0.28%
1/361 • 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.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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 hypertension
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Respiratory failure
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Diabetic foot
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Knee operation
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Hypertensive crisis
|
0.27%
1/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Orthostatic hypotension
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Aortic valve incompetence
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Arrhythmia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Atrial fibrillation
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.56%
2/359 • 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.
|
0.58%
2/342 • 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.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Stress cardiomyopathy
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Blood and lymphatic system disorders
Mesenteric lymphadenitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Epiretinal membrane
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Glaucoma
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Iridocyclitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Iris neovascularisation
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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 hole
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Posterior capsule opacification
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 detachment
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Vitritis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Diverticulum intestinal haemorrhagic
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 ulcer
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Gastrointestinal inflammation
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Large intestine polyp
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Asthenia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.58%
2/342 • 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.
|
|
General disorders
Death
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.56%
2/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Stent-graft endoleak
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Chest pain
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/361 • 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.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Bronchitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
COVID-19 pneumonia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Cellulitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Clostridium difficile infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Device related infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Escherichia urinary tract infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Influenza
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Kidney infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Lower respiratory tract infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Necrotising fasciitis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Pneumonia viral
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Respiratory syncytial virus infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Tooth infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Urinary tract candidiasis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Urinary tract infection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Urosepsis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.58%
2/342 • 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Hip fracture
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Lower limb fracture
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Rib fracture
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Road traffic accident
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Shunt stenosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Thermal burn
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Dehydration
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Back pain
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Joint effusion
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Mobility decreased
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Polymyositis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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)
Benign neoplasm of thyroid gland
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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)
Bladder cancer
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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)
Papillary thyroid cancer
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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)
Thyroid cancer
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Hypoaesthesia
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Presyncope
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Syncope
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.58%
2/342 • 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.
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
End stage renal disease
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Nephrolithiasis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Nephropathy
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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 failure
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Cystocele
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Acute respiratory failure
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Obstructive sleep apnoea syndrome
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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 oedema
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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
Ligament operation
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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
Renal transplant
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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%
0/342 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
Aortic stenosis
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.28%
1/359 • 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.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
|
Vascular disorders
Secondary hypertension
|
0.00%
0/365 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
0/359 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
0.29%
1/342 • 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.
|
Other adverse events
| Measure |
Arm A: Faricimab Q4W (Part 1)
n=365 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by 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=361 participants at risk
In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by 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=359 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=342 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).
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
2.7%
10/365 • 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.
|
3.9%
14/361 • 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.
|
2.8%
10/359 • 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.
|
2.0%
7/342 • 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
Vitreous detachment
|
3.0%
11/365 • 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.
|
2.5%
9/361 • 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.
|
1.7%
6/359 • 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.
|
4.1%
14/342 • 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.
|
|
Infections and infestations
COVID-19
|
3.8%
14/365 • 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.
|
3.3%
12/361 • 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.
|
11.7%
42/359 • Number of events 42 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
13.5%
46/342 • Number of events 46 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
2.5%
9/365 • 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.
|
3.3%
12/361 • Number of events 22 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
4.5%
16/359 • 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.
|
4.4%
15/342 • Number of events 34 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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
|
4.1%
15/365 • Number of events 15 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.8%
10/361 • 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.
|
3.3%
12/359 • Number of events 13 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For ocular AEs, the number of participants and events reported per term are specified to have occurred in the study eye or the fellow eye.
|
2.3%
8/342 • 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
Cataract
|
0.82%
3/365 • 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.
|
1.9%
7/361 • 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.
|
3.9%
14/359 • 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.
|
4.1%
14/342 • 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.
|
|
Eye disorders
Cystoid macular oedema
|
0.27%
1/365 • 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.
|
0.83%
3/361 • 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.
|
3.1%
11/359 • Number of events 15 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
10/342 • 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.
|
|
Eye disorders
Macular oedema
|
0.55%
2/365 • 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%
0/361 • Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
Adverse events (AEs) are reported for the safety population, which includes all participants who received ≥1 injection of active study drug (faricimab or aflibercept) in the study eye. For Part 2, safety analysis included: in Arm A, those with Week 24 treatment or dose hold, or if none, follow-up beyond Day 168; in Arm B, those who received ≥1 faricimab dose. For 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%
7/359 • 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.
|
4.1%
14/342 • 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.
|
|
Eye disorders
Epiretinal membrane
|
0.82%
3/365 • 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.
|
0.55%
2/361 • 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.
|
0.84%
3/359 • 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.
|
3.2%
11/342 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
5/365 • 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.
|
1.9%
7/361 • 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.
|
2.8%
10/359 • 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.
|
4.7%
16/342 • 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.
|
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