Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE) (NCT NCT03823300)
NCT ID: NCT03823300
Last Updated: 2025-07-11
Results Overview
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
658 participants
Primary outcome timeframe
From Baseline through Week 48
Results posted on
2025-07-11
Participant Flow
A total of 1012 patients were screened, 354 of whom failed screening, most commonly due to not meeting inclusion criteria. A total of 658 treatment-naive patients with nAMD were randomized 1:1 into the study: 331 to the faricimab arm and 327 to the aflibercept arm.
Participant milestones
| Measure |
Arm A: Faricimab
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Overall Study
STARTED
|
331
|
327
|
|
Overall Study
Received at Least One Dose of Study Drug
|
331
|
326
|
|
Overall Study
Completed up to Week 48
|
321
|
309
|
|
Overall Study
COMPLETED
|
297
|
273
|
|
Overall Study
NOT COMPLETED
|
34
|
54
|
Reasons for withdrawal
| Measure |
Arm A: Faricimab
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
22
|
|
Overall Study
Death
|
10
|
14
|
|
Overall Study
Adverse Event
|
3
|
5
|
|
Overall Study
Physician Decision
|
1
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Not Eligible
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)
Baseline characteristics by cohort
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
Total
n=658 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.8 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
76.1 Years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
75.5 Years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
203 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
391 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
287 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
561 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
278 Participants
n=5 Participants
|
270 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States and Canada
|
135 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Region of Enrollment
Asia
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
Rest of the World
|
161 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Right or Left) Chosen as the Study Eye
Right Eye
|
168 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
338 Participants
n=5 Participants
|
|
Number of Participants by the Eye (Right or Left) Chosen as the Study Eye
Left Eye
|
163 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye
|
58.7 ETDRS Letters
STANDARD_DEVIATION 14.0 • n=5 Participants
|
58.9 ETDRS Letters
STANDARD_DEVIATION 13.3 • n=7 Participants
|
58.8 ETDRS Letters
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≥74 Letters
|
45 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
73 to 55 Letters
|
181 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Number of Participants by the BCVA Letter Score Categories in the Study Eye
≤54 Letters
|
105 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye
<33 Letters
|
238 Participants
n=5 Participants
|
234 Participants
n=7 Participants
|
472 Participants
n=5 Participants
|
|
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye
≥33 Letters
|
89 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Number of Participants by the Low Luminance Deficit (LLD) Letter Score Categories in the Study Eye
Missing/Invalid
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Occult
|
171 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Classic
|
98 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Minimally Classic
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Retinal Angiomatous Proliferation (RAP)
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Predominantly Classic
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Polypoidal Choroidal Vasculopathy (PCV)
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Choroidal Neovascularization (CNV) Lesion Type in the Study Eye by Fundus Fluorescein Angiography
Missing
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline through Week 48Population: 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 adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
|
6.6 ETDRS Letters
Interval 5.3 to 7.8
|
6.6 ETDRS Letters
Interval 5.3 to 7.8
|
SECONDARY outcome
Timeframe: From Baseline through Week 60Population: 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 adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
|
6.6 ETDRS Letters
Interval 5.3 to 7.9
|
7.1 ETDRS Letters
Interval 5.8 to 8.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: 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 adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (\<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% CI is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 4
|
5.1 ETDRS Letters
Interval 4.2 to 5.9
|
4.3 ETDRS Letters
Interval 3.5 to 5.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 16
|
6.7 ETDRS Letters
Interval 5.6 to 7.7
|
6.4 ETDRS Letters
Interval 5.4 to 7.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 20
|
7.0 ETDRS Letters
Interval 5.9 to 8.1
|
6.8 ETDRS Letters
Interval 5.7 to 7.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 24
|
7.0 ETDRS Letters
Interval 5.8 to 8.1
|
6.5 ETDRS Letters
Interval 5.4 to 7.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 28
|
7.1 ETDRS Letters
Interval 5.9 to 8.2
|
6.8 ETDRS Letters
Interval 5.6 to 7.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 32
|
7.2 ETDRS Letters
Interval 6.0 to 8.3
|
6.9 ETDRS Letters
Interval 5.7 to 8.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 36
|
6.7 ETDRS Letters
Interval 5.5 to 7.9
|
6.8 ETDRS Letters
Interval 5.6 to 8.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 48
|
6.5 ETDRS Letters
Interval 5.1 to 7.8
|
6.4 ETDRS Letters
Interval 5.0 to 7.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 52
|
6.4 ETDRS Letters
Interval 5.1 to 7.7
|
6.9 ETDRS Letters
Interval 5.5 to 8.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 56
|
7.1 ETDRS Letters
Interval 5.7 to 8.4
|
7.4 ETDRS Letters
Interval 6.0 to 8.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 60
|
6.3 ETDRS Letters
Interval 4.9 to 7.7
|
6.9 ETDRS Letters
Interval 5.5 to 8.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 64
|
6.5 ETDRS Letters
Interval 5.1 to 8.0
|
6.1 ETDRS Letters
Interval 4.7 to 7.6
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 88
|
5.6 ETDRS Letters
Interval 4.1 to 7.1
|
5.4 ETDRS Letters
Interval 3.9 to 7.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 92
|
5.7 ETDRS Letters
Interval 4.2 to 7.2
|
5.4 ETDRS Letters
Interval 3.9 to 7.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 100
|
5.2 ETDRS Letters
Interval 3.6 to 6.8
|
4.9 ETDRS Letters
Interval 3.3 to 6.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 104
|
5.0 ETDRS Letters
Interval 3.4 to 6.6
|
5.3 ETDRS Letters
Interval 3.7 to 6.9
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 108
|
5.2 ETDRS Letters
Interval 3.5 to 6.8
|
5.4 ETDRS Letters
Interval 3.7 to 7.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 112
|
4.8 ETDRS Letters
Interval 3.2 to 6.5
|
4.8 ETDRS Letters
Interval 3.1 to 6.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 8
|
6.0 ETDRS Letters
Interval 5.1 to 6.9
|
5.8 ETDRS Letters
Interval 4.9 to 6.8
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 12
|
7.0 ETDRS Letters
Interval 6.1 to 8.0
|
6.4 ETDRS Letters
Interval 5.4 to 7.4
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 40
|
6.8 ETDRS Letters
Interval 5.5 to 8.1
|
6.7 ETDRS Letters
Interval 5.4 to 8.0
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 44
|
6.5 ETDRS Letters
Interval 5.3 to 7.8
|
6.4 ETDRS Letters
Interval 5.2 to 7.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 68
|
6.2 ETDRS Letters
Interval 4.8 to 7.6
|
6.7 ETDRS Letters
Interval 5.3 to 8.1
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 72
|
6.4 ETDRS Letters
Interval 4.9 to 7.8
|
6.2 ETDRS Letters
Interval 4.8 to 7.7
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 76
|
6.4 ETDRS Letters
Interval 4.9 to 7.9
|
6.0 ETDRS Letters
Interval 4.6 to 7.5
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 80
|
5.9 ETDRS Letters
Interval 4.4 to 7.4
|
5.6 ETDRS Letters
Interval 4.1 to 7.2
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 84
|
5.9 ETDRS Letters
Interval 4.3 to 7.5
|
5.8 ETDRS Letters
Interval 4.2 to 7.3
|
|
Change From Baseline in BCVA in the Study Eye Over Time
Week 96
|
5.4 ETDRS Letters
Interval 3.9 to 7.0
|
5.5 ETDRS Letters
Interval 3.9 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 40, 44, and 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=302 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=291 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Gaining ≥15 Letters
|
20.2 Percentage of participants
Interval 15.9 to 24.6
|
22.2 Percentage of participants
Interval 17.7 to 26.8
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Gaining ≥5 Letters
|
60.5 Percentage of participants
Interval 55.2 to 65.7
|
59.4 Percentage of participants
Interval 53.9 to 64.9
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Gaining ≥0 Letters
|
82.2 Percentage of participants
Interval 77.9 to 86.4
|
79.1 Percentage of participants
Interval 74.5 to 83.6
|
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Gaining ≥10 Letters
|
39.2 Percentage of participants
Interval 34.1 to 44.4
|
35.8 Percentage of participants
Interval 30.6 to 40.9
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 52, 56, and 60Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=289 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=276 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
|
22.6 Percentage of participants
Interval 18.1 to 27.1
|
23.7 Percentage of participants
Interval 19.1 to 28.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
10.5 Percentage of participants
Interval 7.2 to 13.7
|
9.5 Percentage of participants
Interval 6.4 to 12.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
17.3 Percentage of participants
Interval 13.3 to 21.3
|
17.7 Percentage of participants
Interval 13.6 to 21.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
20.2 Percentage of participants
Interval 15.9 to 24.4
|
20.2 Percentage of participants
Interval 15.9 to 24.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
22.6 Percentage of participants
Interval 18.0 to 27.2
|
19.5 Percentage of participants
Interval 15.1 to 23.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
23.7 Percentage of participants
Interval 19.0 to 28.3
|
25.4 Percentage of participants
Interval 20.6 to 30.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
21.5 Percentage of participants
Interval 17.1 to 26.0
|
22.4 Percentage of participants
Interval 17.7 to 27.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
22.3 Percentage of participants
Interval 17.7 to 26.9
|
23.1 Percentage of participants
Interval 18.3 to 27.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
22.7 Percentage of participants
Interval 18.1 to 27.2
|
23.4 Percentage of participants
Interval 18.7 to 28.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
22.6 Percentage of participants
Interval 18.1 to 27.1
|
25.8 Percentage of participants
Interval 20.9 to 30.7
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
24.5 Percentage of participants
Interval 19.7 to 29.3
|
24.9 Percentage of participants
Interval 20.0 to 29.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
22.6 Percentage of participants
Interval 17.9 to 27.2
|
27.1 Percentage of participants
Interval 22.0 to 32.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
22.1 Percentage of participants
Interval 17.4 to 26.8
|
24.9 Percentage of participants
Interval 20.1 to 29.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
24.1 Percentage of participants
Interval 19.3 to 29.0
|
24.4 Percentage of participants
Interval 19.5 to 29.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
22.5 Percentage of participants
Interval 17.8 to 27.2
|
24.8 Percentage of participants
Interval 19.9 to 29.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
25.7 Percentage of participants
Interval 20.8 to 30.6
|
25.5 Percentage of participants
Interval 20.5 to 30.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
24.8 Percentage of participants
Interval 19.9 to 29.8
|
23.1 Percentage of participants
Interval 18.3 to 28.0
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
22.5 Percentage of participants
Interval 17.7 to 27.3
|
24.6 Percentage of participants
Interval 19.6 to 29.5
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
21.6 Percentage of participants
Interval 16.8 to 26.3
|
22.3 Percentage of participants
Interval 17.5 to 27.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
13.9 Percentage of participants
Interval 10.3 to 17.5
|
13.5 Percentage of participants
Interval 10.0 to 17.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
17.7 Percentage of participants
Interval 13.7 to 21.6
|
17.2 Percentage of participants
Interval 13.3 to 21.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
19.3 Percentage of participants
Interval 14.9 to 23.6
|
18.9 Percentage of participants
Interval 14.6 to 23.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
23.7 Percentage of participants
Interval 19.1 to 28.3
|
20.8 Percentage of participants
Interval 16.1 to 25.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
22.2 Percentage of participants
Interval 17.7 to 26.6
|
20.6 Percentage of participants
Interval 16.1 to 25.0
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
25.9 Percentage of participants
Interval 21.1 to 30.7
|
27.0 Percentage of participants
Interval 22.0 to 32.0
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
25.4 Percentage of participants
Interval 20.6 to 30.2
|
21.2 Percentage of participants
Interval 16.5 to 25.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
22.9 Percentage of participants
Interval 18.1 to 27.7
|
25.8 Percentage of participants
Interval 20.8 to 30.7
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
23.7 Percentage of participants
Interval 18.9 to 28.5
|
25.6 Percentage of participants
Interval 20.6 to 30.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
25.2 Percentage of participants
Interval 20.3 to 30.1
|
22.5 Percentage of participants
Interval 17.8 to 27.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
24.2 Percentage of participants
Interval 19.8 to 28.7
|
22.1 Percentage of participants
Interval 17.7 to 26.5
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
32.4 Percentage of participants
Interval 27.5 to 37.2
|
28.7 Percentage of participants
Interval 24.1 to 33.4
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
39.2 Percentage of participants
Interval 33.8 to 44.5
|
35.2 Percentage of participants
Interval 29.9 to 40.5
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
40.5 Percentage of participants
Interval 35.1 to 45.8
|
36.0 Percentage of participants
Interval 30.5 to 41.4
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
38.9 Percentage of participants
Interval 33.6 to 44.2
|
38.9 Percentage of participants
Interval 33.5 to 44.3
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
42.3 Percentage of participants
Interval 36.8 to 47.8
|
39.5 Percentage of participants
Interval 34.1 to 45.0
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
41.0 Percentage of participants
Interval 35.5 to 46.5
|
38.6 Percentage of participants
Interval 33.2 to 43.9
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
44.2 Percentage of participants
Interval 38.8 to 49.7
|
43.6 Percentage of participants
Interval 38.1 to 49.2
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
40.1 Percentage of participants
Interval 34.7 to 45.5
|
40.7 Percentage of participants
Interval 35.3 to 46.2
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
42.1 Percentage of participants
Interval 36.5 to 47.8
|
41.0 Percentage of participants
Interval 35.3 to 46.7
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
44.0 Percentage of participants
Interval 38.3 to 49.7
|
36.2 Percentage of participants
Interval 30.5 to 41.9
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
34.2 Percentage of participants
Interval 29.3 to 39.1
|
34.6 Percentage of participants
Interval 29.5 to 39.7
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
35.3 Percentage of participants
Interval 30.3 to 40.4
|
34.2 Percentage of participants
Interval 29.2 to 39.3
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
37.8 Percentage of participants
Interval 32.7 to 42.9
|
34.3 Percentage of participants
Interval 29.2 to 39.4
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
40.5 Percentage of participants
Interval 35.1 to 46.0
|
35.0 Percentage of participants
Interval 29.7 to 40.3
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
40.9 Percentage of participants
Interval 35.5 to 46.3
|
39.3 Percentage of participants
Interval 34.0 to 44.7
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
44.2 Percentage of participants
Interval 38.8 to 49.7
|
42.1 Percentage of participants
Interval 36.6 to 47.6
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
43.1 Percentage of participants
Interval 37.6 to 48.6
|
42.4 Percentage of participants
Interval 36.8 to 47.9
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
44.0 Percentage of participants
Interval 38.5 to 49.5
|
41.1 Percentage of participants
Interval 35.4 to 46.8
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
42.0 Percentage of participants
Interval 36.5 to 47.4
|
38.9 Percentage of participants
Interval 33.4 to 44.3
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
42.2 Percentage of participants
Interval 36.7 to 47.8
|
40.7 Percentage of participants
Interval 35.1 to 46.2
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
44.2 Percentage of participants
Interval 38.6 to 49.9
|
41.9 Percentage of participants
Interval 36.2 to 47.6
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
42.7 Percentage of participants
Interval 37.2 to 48.3
|
41.4 Percentage of participants
Interval 35.6 to 47.2
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
40.3 Percentage of participants
Interval 34.8 to 45.9
|
39.4 Percentage of participants
Interval 33.7 to 45.1
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
41.1 Percentage of participants
Interval 35.5 to 46.7
|
39.1 Percentage of participants
Interval 33.3 to 45.0
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
40.2 Percentage of participants
Interval 34.6 to 45.7
|
34.6 Percentage of participants
Interval 29.0 to 40.1
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
41.7 Percentage of participants
Interval 36.0 to 47.4
|
38.0 Percentage of participants
Interval 32.2 to 43.8
|
|
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
41.3 Percentage of participants
Interval 35.7 to 47.0
|
35.0 Percentage of participants
Interval 29.6 to 40.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
63.9 Percentage of participants
Interval 58.9 to 68.9
|
57.6 Percentage of participants
Interval 52.3 to 62.9
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
61.7 Percentage of participants
Interval 56.5 to 66.8
|
59.6 Percentage of participants
Interval 54.3 to 64.9
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
64.1 Percentage of participants
Interval 59.0 to 69.2
|
60.9 Percentage of participants
Interval 55.6 to 66.3
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
63.3 Percentage of participants
Interval 58.0 to 68.7
|
60.1 Percentage of participants
Interval 54.6 to 65.6
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
61.4 Percentage of participants
Interval 56.0 to 66.9
|
60.4 Percentage of participants
Interval 54.9 to 65.9
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
63.5 Percentage of participants
Interval 58.1 to 68.9
|
60.9 Percentage of participants
Interval 55.5 to 66.4
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
65.2 Percentage of participants
Interval 59.8 to 70.6
|
63.1 Percentage of participants
Interval 57.5 to 68.8
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
62.6 Percentage of participants
Interval 57.1 to 68.1
|
60.7 Percentage of participants
Interval 54.9 to 66.5
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
61.7 Percentage of participants
Interval 56.1 to 67.3
|
56.9 Percentage of participants
Interval 50.9 to 62.9
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
60.3 Percentage of participants
Interval 54.6 to 66.0
|
59.3 Percentage of participants
Interval 53.3 to 65.3
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
62.4 Percentage of participants
Interval 56.8 to 68.0
|
58.0 Percentage of participants
Interval 51.8 to 64.1
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
59.9 Percentage of participants
Interval 54.2 to 65.6
|
59.4 Percentage of participants
Interval 53.4 to 65.3
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
47.8 Percentage of participants
Interval 42.6 to 53.0
|
47.5 Percentage of participants
Interval 42.2 to 52.8
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
56.8 Percentage of participants
Interval 51.6 to 62.0
|
54.6 Percentage of participants
Interval 49.3 to 59.8
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
62.2 Percentage of participants
Interval 56.8 to 67.6
|
60.2 Percentage of participants
Interval 54.7 to 65.7
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
63.6 Percentage of participants
Interval 58.2 to 68.9
|
60.5 Percentage of participants
Interval 54.8 to 66.2
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
60.1 Percentage of participants
Interval 54.6 to 65.6
|
62.3 Percentage of participants
Interval 56.7 to 67.8
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
60.0 Percentage of participants
Interval 54.5 to 65.6
|
63.5 Percentage of participants
Interval 57.9 to 69.1
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
63.5 Percentage of participants
Interval 58.1 to 69.0
|
67.2 Percentage of participants
Interval 61.7 to 72.6
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
64.1 Percentage of participants
Interval 58.7 to 69.5
|
66.5 Percentage of participants
Interval 61.0 to 72.0
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
61.6 Percentage of participants
Interval 56.1 to 67.2
|
65.5 Percentage of participants
Interval 59.9 to 71.0
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
63.0 Percentage of participants
Interval 57.4 to 68.5
|
64.0 Percentage of participants
Interval 58.5 to 69.6
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
64.1 Percentage of participants
Interval 58.6 to 69.6
|
66.6 Percentage of participants
Interval 60.9 to 72.2
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
63.9 Percentage of participants
Interval 58.2 to 69.6
|
58.7 Percentage of participants
Interval 53.0 to 64.4
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
63.3 Percentage of participants
Interval 57.7 to 68.9
|
62.3 Percentage of participants
Interval 56.6 to 67.9
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
61.6 Percentage of participants
Interval 56.1 to 67.2
|
64.3 Percentage of participants
Interval 58.6 to 70.1
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
62.7 Percentage of participants
Interval 57.1 to 68.3
|
58.3 Percentage of participants
Interval 52.6 to 64.0
|
|
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
61.3 Percentage of participants
Interval 55.6 to 67.0
|
61.0 Percentage of participants
Interval 55.1 to 67.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
80.5 Percentage of participants
Interval 76.3 to 84.7
|
74.2 Percentage of participants
Interval 69.5 to 78.9
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
82.3 Percentage of participants
Interval 78.3 to 86.3
|
80.3 Percentage of participants
Interval 76.0 to 84.5
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
84.1 Percentage of participants
Interval 80.3 to 88.0
|
81.0 Percentage of participants
Interval 76.8 to 85.1
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
82.6 Percentage of participants
Interval 78.5 to 86.6
|
83.0 Percentage of participants
Interval 78.9 to 87.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
84.8 Percentage of participants
Interval 80.9 to 88.6
|
83.1 Percentage of participants
Interval 79.1 to 87.2
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
82.8 Percentage of participants
Interval 78.6 to 86.9
|
82.0 Percentage of participants
Interval 77.6 to 86.4
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
82.7 Percentage of participants
Interval 78.5 to 86.8
|
83.0 Percentage of participants
Interval 78.7 to 87.4
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
80.3 Percentage of participants
Interval 75.9 to 84.7
|
82.2 Percentage of participants
Interval 77.8 to 86.5
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
81.2 Percentage of participants
Interval 76.8 to 85.6
|
76.5 Percentage of participants
Interval 71.7 to 81.3
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
82.0 Percentage of participants
Interval 77.6 to 86.3
|
77.6 Percentage of participants
Interval 72.9 to 82.3
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
82.7 Percentage of participants
Interval 78.3 to 87.1
|
78.9 Percentage of participants
Interval 74.1 to 83.6
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
79.4 Percentage of participants
Interval 74.8 to 84.0
|
84.7 Percentage of participants
Interval 80.5 to 88.9
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
80.7 Percentage of participants
Interval 76.1 to 85.2
|
82.6 Percentage of participants
Interval 78.2 to 87.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
78.9 Percentage of participants
Interval 74.2 to 83.6
|
81.5 Percentage of participants
Interval 77.0 to 86.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
81.3 Percentage of participants
Interval 76.8 to 85.8
|
81.1 Percentage of participants
Interval 76.5 to 85.7
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
79.5 Percentage of participants
Interval 74.8 to 84.1
|
78.8 Percentage of participants
Interval 74.0 to 83.6
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
81.0 Percentage of participants
Interval 76.4 to 85.6
|
79.8 Percentage of participants
Interval 75.2 to 84.5
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
80.0 Percentage of participants
Interval 75.3 to 84.7
|
76.0 Percentage of participants
Interval 71.0 to 81.1
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
78.7 Percentage of participants
Interval 73.9 to 83.5
|
81.0 Percentage of participants
Interval 76.3 to 85.7
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
78.7 Percentage of participants
Interval 73.9 to 83.5
|
80.6 Percentage of participants
Interval 75.9 to 85.4
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
81.3 Percentage of participants
Interval 76.7 to 85.8
|
76.3 Percentage of participants
Interval 71.2 to 81.4
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
76.3 Percentage of participants
Interval 71.3 to 81.3
|
77.5 Percentage of participants
Interval 72.5 to 82.6
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
75.7 Percentage of participants
Interval 70.8 to 80.7
|
74.8 Percentage of participants
Interval 69.6 to 80.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
76.6 Percentage of participants
Interval 71.6 to 81.6
|
79.0 Percentage of participants
Interval 74.0 to 84.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
74.6 Percentage of participants
Interval 69.5 to 79.8
|
77.4 Percentage of participants
Interval 72.3 to 82.5
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
84.0 Percentage of participants
Interval 79.8 to 88.2
|
78.6 Percentage of participants
Interval 73.9 to 83.2
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
80.5 Percentage of participants
Interval 76.0 to 85.1
|
80.4 Percentage of participants
Interval 75.8 to 85.0
|
|
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
78.8 Percentage of participants
Interval 74.0 to 83.6
|
76.9 Percentage of participants
Interval 71.7 to 82.1
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 40, 44, and 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=302 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=291 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Avoiding a Loss of ≥15 Letters
|
95.8 Percentage of participants
Interval 93.6 to 98.0
|
97.3 Percentage of participants
Interval 95.5 to 99.1
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Avoiding a Loss of ≥10 Letters
|
93.8 Percentage of participants
Interval 91.1 to 96.4
|
94.6 Percentage of participants
Interval 92.2 to 97.1
|
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48
Avoiding a Loss of ≥5 Letters
|
91.2 Percentage of participants
Interval 88.0 to 94.3
|
88.5 Percentage of participants
Interval 85.0 to 92.0
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 52, 56, and 60Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 52, 56, or 60 were included in this analysis.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=289 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=276 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60
|
96.5 Percentage of participants
Interval 94.4 to 98.6
|
96.1 Percentage of participants
Interval 94.0 to 98.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
98.5 Percentage of participants
Interval 97.3 to 99.8
|
97.8 Percentage of participants
Interval 96.3 to 99.4
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
98.5 Percentage of participants
Interval 97.3 to 99.8
|
98.1 Percentage of participants
Interval 96.7 to 99.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
97.3 Percentage of participants
Interval 95.5 to 99.0
|
98.4 Percentage of participants
Interval 97.0 to 99.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
96.6 Percentage of participants
Interval 94.6 to 98.6
|
97.2 Percentage of participants
Interval 95.4 to 99.1
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
97.0 Percentage of participants
Interval 95.1 to 98.9
|
97.8 Percentage of participants
Interval 96.2 to 99.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
96.2 Percentage of participants
Interval 94.1 to 98.4
|
97.6 Percentage of participants
Interval 95.9 to 99.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
95.9 Percentage of participants
Interval 93.6 to 98.1
|
96.4 Percentage of participants
Interval 94.3 to 98.5
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
95.8 Percentage of participants
Interval 93.5 to 98.0
|
96.9 Percentage of participants
Interval 95.0 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
99.4 Percentage of participants
Interval 98.6 to 100.0
|
98.1 Percentage of participants
Interval 96.7 to 99.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
97.6 Percentage of participants
Interval 96.0 to 99.2
|
98.4 Percentage of participants
Interval 97.0 to 99.8
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
97.0 Percentage of participants
Interval 95.1 to 98.9
|
96.9 Percentage of participants
Interval 95.0 to 98.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
97.0 Percentage of participants
Interval 95.2 to 98.9
|
96.5 Percentage of participants
Interval 94.5 to 98.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
94.9 Percentage of participants
Interval 92.5 to 97.4
|
96.8 Percentage of participants
Interval 94.8 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
96.1 Percentage of participants
Interval 93.9 to 98.3
|
96.8 Percentage of participants
Interval 94.8 to 98.8
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
95.0 Percentage of participants
Interval 92.5 to 97.5
|
96.1 Percentage of participants
Interval 94.0 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
96.4 Percentage of participants
Interval 94.3 to 98.5
|
94.9 Percentage of participants
Interval 92.3 to 97.4
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
94.7 Percentage of participants
Interval 92.1 to 97.2
|
96.0 Percentage of participants
Interval 93.7 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
94.5 Percentage of participants
Interval 91.9 to 97.2
|
95.4 Percentage of participants
Interval 92.9 to 97.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
94.9 Percentage of participants
Interval 92.3 to 97.4
|
93.7 Percentage of participants
Interval 90.9 to 96.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
93.9 Percentage of participants
Interval 91.1 to 96.6
|
93.3 Percentage of participants
Interval 90.4 to 96.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
92.5 Percentage of participants
Interval 89.5 to 95.5
|
93.8 Percentage of participants
Interval 90.9 to 96.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
94.1 Percentage of participants
Interval 91.4 to 96.7
|
94.3 Percentage of participants
Interval 91.5 to 97.0
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
93.0 Percentage of participants
Interval 90.2 to 95.9
|
94.6 Percentage of participants
Interval 92.0 to 97.2
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
92.6 Percentage of participants
Interval 89.6 to 95.6
|
95.0 Percentage of participants
Interval 92.5 to 97.6
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
92.5 Percentage of participants
Interval 89.5 to 95.5
|
93.9 Percentage of participants
Interval 91.1 to 96.7
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
92.9 Percentage of participants
Interval 90.0 to 95.9
|
94.0 Percentage of participants
Interval 91.0 to 96.9
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
92.3 Percentage of participants
Interval 89.2 to 95.3
|
93.3 Percentage of participants
Interval 90.3 to 96.3
|
|
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
91.8 Percentage of participants
Interval 88.7 to 95.0
|
93.0 Percentage of participants
Interval 89.9 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, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
90.7 Percentage of participants
Interval 87.4 to 94.0
|
91.6 Percentage of participants
Interval 88.3 to 94.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
98.5 Percentage of participants
Interval 97.2 to 99.8
|
96.2 Percentage of participants
Interval 94.1 to 98.3
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
97.0 Percentage of participants
Interval 95.3 to 98.7
|
96.9 Percentage of participants
Interval 95.0 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
97.0 Percentage of participants
Interval 95.2 to 98.8
|
96.8 Percentage of participants
Interval 94.9 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
96.6 Percentage of participants
Interval 94.7 to 98.5
|
96.8 Percentage of participants
Interval 94.9 to 98.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
95.2 Percentage of participants
Interval 92.9 to 97.4
|
96.1 Percentage of participants
Interval 94.0 to 98.2
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
95.2 Percentage of participants
Interval 92.9 to 97.6
|
95.5 Percentage of participants
Interval 93.2 to 97.8
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
95.0 Percentage of participants
Interval 92.6 to 97.4
|
95.2 Percentage of participants
Interval 92.7 to 97.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
94.6 Percentage of participants
Interval 92.1 to 97.1
|
95.9 Percentage of participants
Interval 93.7 to 98.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
95.3 Percentage of participants
Interval 93.0 to 97.7
|
94.4 Percentage of participants
Interval 91.8 to 97.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
93.8 Percentage of participants
Interval 91.1 to 96.5
|
94.6 Percentage of participants
Interval 92.2 to 97.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
94.1 Percentage of participants
Interval 91.4 to 96.8
|
92.1 Percentage of participants
Interval 89.1 to 95.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
92.2 Percentage of participants
Interval 89.2 to 95.3
|
94.8 Percentage of participants
Interval 92.3 to 97.3
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
91.4 Percentage of participants
Interval 88.2 to 94.6
|
93.8 Percentage of participants
Interval 91.1 to 96.6
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
93.3 Percentage of participants
Interval 90.5 to 96.2
|
95.0 Percentage of participants
Interval 92.5 to 97.5
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
91.4 Percentage of participants
Interval 88.2 to 94.6
|
93.2 Percentage of participants
Interval 90.4 to 96.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
93.5 Percentage of participants
Interval 90.7 to 96.4
|
92.3 Percentage of participants
Interval 89.3 to 95.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
91.9 Percentage of participants
Interval 88.8 to 95.0
|
92.9 Percentage of participants
Interval 89.9 to 96.0
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
92.4 Percentage of participants
Interval 89.3 to 95.5
|
91.6 Percentage of participants
Interval 88.3 to 94.9
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
93.1 Percentage of participants
Interval 90.2 to 96.0
|
90.1 Percentage of participants
Interval 86.5 to 93.6
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
92.1 Percentage of participants
Interval 89.0 to 95.2
|
89.9 Percentage of participants
Interval 86.3 to 93.5
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
90.3 Percentage of participants
Interval 86.9 to 93.7
|
91.8 Percentage of participants
Interval 88.4 to 95.1
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
90.8 Percentage of participants
Interval 87.5 to 94.1
|
92.3 Percentage of participants
Interval 89.1 to 95.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
90.7 Percentage of participants
Interval 87.4 to 94.1
|
91.0 Percentage of participants
Interval 87.6 to 94.5
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
90.4 Percentage of participants
Interval 87.0 to 93.8
|
92.6 Percentage of participants
Interval 89.4 to 95.8
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
89.0 Percentage of participants
Interval 85.4 to 92.7
|
92.2 Percentage of participants
Interval 88.9 to 95.4
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
88.5 Percentage of participants
Interval 84.8 to 92.3
|
91.2 Percentage of participants
Interval 87.7 to 94.7
|
|
Percentage of Participants Avoiding a Loss of ≥10 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
88.5 Percentage of participants
Interval 84.7 to 92.2
|
89.5 Percentage of participants
Interval 85.8 to 93.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 4
|
93.0 Percentage of participants
Interval 90.4 to 95.6
|
91.8 Percentage of participants
Interval 88.9 to 94.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 8
|
93.1 Percentage of participants
Interval 90.4 to 95.7
|
94.1 Percentage of participants
Interval 91.5 to 96.6
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 12
|
93.3 Percentage of participants
Interval 90.7 to 95.9
|
91.8 Percentage of participants
Interval 88.8 to 94.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 16
|
91.7 Percentage of participants
Interval 88.7 to 94.6
|
90.8 Percentage of participants
Interval 87.7 to 94.0
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 20
|
92.0 Percentage of participants
Interval 89.1 to 94.9
|
92.9 Percentage of participants
Interval 90.0 to 95.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 24
|
90.6 Percentage of participants
Interval 87.4 to 93.9
|
91.7 Percentage of participants
Interval 88.6 to 94.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 28
|
91.0 Percentage of participants
Interval 87.9 to 94.1
|
90.2 Percentage of participants
Interval 86.7 to 93.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 32
|
89.9 Percentage of participants
Interval 86.5 to 93.2
|
91.0 Percentage of participants
Interval 87.7 to 94.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 36
|
90.7 Percentage of participants
Interval 87.5 to 94.0
|
87.4 Percentage of participants
Interval 83.6 to 91.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 40
|
91.7 Percentage of participants
Interval 88.6 to 94.9
|
88.1 Percentage of participants
Interval 84.5 to 91.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 44
|
90.9 Percentage of participants
Interval 87.7 to 94.2
|
88.8 Percentage of participants
Interval 85.3 to 92.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 48
|
89.4 Percentage of participants
Interval 85.9 to 93.0
|
88.6 Percentage of participants
Interval 85.0 to 92.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 52
|
88.9 Percentage of participants
Interval 85.3 to 92.5
|
91.7 Percentage of participants
Interval 88.6 to 94.8
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 56
|
89.5 Percentage of participants
Interval 86.0 to 93.0
|
88.8 Percentage of participants
Interval 85.2 to 92.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 60
|
86.7 Percentage of participants
Interval 82.9 to 90.6
|
88.8 Percentage of participants
Interval 85.2 to 92.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 64
|
87.8 Percentage of participants
Interval 84.1 to 91.6
|
86.0 Percentage of participants
Interval 82.0 to 90.1
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 68
|
88.2 Percentage of participants
Interval 84.5 to 91.9
|
87.1 Percentage of participants
Interval 83.2 to 91.0
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 72
|
87.0 Percentage of participants
Interval 83.1 to 90.9
|
87.3 Percentage of participants
Interval 83.4 to 91.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 76
|
87.1 Percentage of participants
Interval 83.2 to 91.1
|
85.4 Percentage of participants
Interval 81.2 to 89.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 80
|
87.3 Percentage of participants
Interval 83.5 to 91.2
|
82.8 Percentage of participants
Interval 78.3 to 87.3
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 84
|
84.1 Percentage of participants
Interval 79.9 to 88.4
|
87.1 Percentage of participants
Interval 83.1 to 91.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 88
|
87.5 Percentage of participants
Interval 83.7 to 91.3
|
86.6 Percentage of participants
Interval 82.5 to 90.6
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 92
|
87.0 Percentage of participants
Interval 83.1 to 90.9
|
87.2 Percentage of participants
Interval 83.2 to 91.2
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 96
|
82.7 Percentage of participants
Interval 78.4 to 87.1
|
86.2 Percentage of participants
Interval 82.1 to 90.4
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 100
|
85.9 Percentage of participants
Interval 81.9 to 89.8
|
84.2 Percentage of participants
Interval 79.9 to 88.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 104
|
83.5 Percentage of participants
Interval 79.1 to 87.8
|
85.4 Percentage of participants
Interval 81.1 to 89.7
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 108
|
84.1 Percentage of participants
Interval 79.9 to 88.4
|
83.9 Percentage of participants
Interval 79.4 to 88.5
|
|
Percentage of Participants Avoiding a Loss of ≥5 Letters From the Baseline BCVA in the Study Eye Over Time
Week 112
|
82.2 Percentage of participants
Interval 77.7 to 86.7
|
84.4 Percentage of participants
Interval 80.0 to 88.8
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 40, 44, and 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=302 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=291 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
|
24.5 Percentage of participants
Interval 19.8 to 29.2
|
26.2 Percentage of participants
Interval 21.2 to 31.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 88
|
29.1 Percentage of participants
Interval 23.8 to 34.4
|
28.4 Percentage of participants
Interval 23.2 to 33.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 4
|
11.3 Percentage of participants
Interval 7.9 to 14.6
|
12.4 Percentage of participants
Interval 8.9 to 15.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 8
|
16.5 Percentage of participants
Interval 12.5 to 20.4
|
16.1 Percentage of participants
Interval 12.2 to 20.0
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 12
|
22.0 Percentage of participants
Interval 17.7 to 26.4
|
21.1 Percentage of participants
Interval 16.7 to 25.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 16
|
21.7 Percentage of participants
Interval 17.4 to 26.1
|
20.7 Percentage of participants
Interval 16.2 to 25.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 20
|
24.9 Percentage of participants
Interval 20.2 to 29.5
|
24.9 Percentage of participants
Interval 20.2 to 29.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 24
|
23.6 Percentage of participants
Interval 18.9 to 28.3
|
23.7 Percentage of participants
Interval 18.9 to 28.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 28
|
27.7 Percentage of participants
Interval 22.7 to 32.7
|
26.9 Percentage of participants
Interval 21.8 to 32.1
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 32
|
28.7 Percentage of participants
Interval 23.6 to 33.8
|
23.2 Percentage of participants
Interval 18.4 to 27.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 36
|
25.9 Percentage of participants
Interval 21.1 to 30.7
|
24.6 Percentage of participants
Interval 19.7 to 29.5
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 40
|
27.9 Percentage of participants
Interval 22.9 to 32.9
|
31.1 Percentage of participants
Interval 25.9 to 36.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 44
|
27.2 Percentage of participants
Interval 22.2 to 32.1
|
28.1 Percentage of participants
Interval 22.8 to 33.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 48
|
27.3 Percentage of participants
Interval 22.3 to 32.4
|
28.3 Percentage of participants
Interval 23.1 to 33.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 52
|
29.2 Percentage of participants
Interval 24.1 to 34.3
|
28.3 Percentage of participants
Interval 23.1 to 33.5
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 56
|
32.0 Percentage of participants
Interval 26.7 to 37.2
|
31.5 Percentage of participants
Interval 26.1 to 36.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 60
|
27.5 Percentage of participants
Interval 22.5 to 32.5
|
31.4 Percentage of participants
Interval 26.0 to 36.8
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 64
|
30.1 Percentage of participants
Interval 25.0 to 35.3
|
27.1 Percentage of participants
Interval 21.9 to 32.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 68
|
28.3 Percentage of participants
Interval 23.1 to 33.4
|
30.0 Percentage of participants
Interval 24.6 to 35.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 72
|
26.4 Percentage of participants
Interval 21.4 to 31.4
|
31.5 Percentage of participants
Interval 26.0 to 36.9
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 76
|
27.4 Percentage of participants
Interval 22.2 to 32.5
|
29.2 Percentage of participants
Interval 23.9 to 34.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 80
|
28.7 Percentage of participants
Interval 23.4 to 34.0
|
31.2 Percentage of participants
Interval 25.7 to 36.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 84
|
28.0 Percentage of participants
Interval 22.8 to 33.1
|
30.1 Percentage of participants
Interval 24.6 to 35.5
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 92
|
27.0 Percentage of participants
Interval 21.8 to 32.1
|
29.0 Percentage of participants
Interval 23.6 to 34.3
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 96
|
30.7 Percentage of participants
Interval 25.3 to 36.0
|
31.1 Percentage of participants
Interval 25.5 to 36.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 100
|
28.6 Percentage of participants
Interval 23.3 to 33.9
|
27.2 Percentage of participants
Interval 22.0 to 32.5
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 104
|
27.2 Percentage of participants
Interval 22.0 to 32.4
|
30.2 Percentage of participants
Interval 24.8 to 35.6
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 108
|
26.3 Percentage of participants
Interval 21.1 to 31.4
|
27.0 Percentage of participants
Interval 21.7 to 32.4
|
|
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time
Week 112
|
29.4 Percentage of participants
Interval 24.1 to 34.7
|
26.5 Percentage of participants
Interval 21.4 to 31.6
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 40, 44, and 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=302 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=291 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
|
55.2 Percentage of participants
Interval 50.1 to 60.2
|
49.4 Percentage of participants
Interval 44.4 to 54.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (\<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 4
|
45.7 Percentage of participants
Interval 41.1 to 50.2
|
40.1 Percentage of participants
Interval 35.8 to 44.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 8
|
50.5 Percentage of participants
Interval 45.8 to 55.1
|
45.2 Percentage of participants
Interval 40.7 to 49.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 12
|
53.5 Percentage of participants
Interval 48.8 to 58.3
|
48.5 Percentage of participants
Interval 43.8 to 53.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 16
|
56.1 Percentage of participants
Interval 51.2 to 60.9
|
47.4 Percentage of participants
Interval 42.8 to 52.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 20
|
57.5 Percentage of participants
Interval 52.6 to 62.4
|
51.1 Percentage of participants
Interval 46.3 to 55.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 24
|
57.4 Percentage of participants
Interval 52.4 to 62.4
|
47.8 Percentage of participants
Interval 42.9 to 52.8
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 28
|
55.2 Percentage of participants
Interval 50.0 to 60.4
|
48.2 Percentage of participants
Interval 43.2 to 53.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 32
|
55.9 Percentage of participants
Interval 50.8 to 61.1
|
49.8 Percentage of participants
Interval 45.0 to 54.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 36
|
56.0 Percentage of participants
Interval 50.9 to 61.0
|
47.4 Percentage of participants
Interval 42.2 to 52.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 40
|
54.7 Percentage of participants
Interval 49.5 to 59.9
|
52.7 Percentage of participants
Interval 47.5 to 57.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 44
|
56.3 Percentage of participants
Interval 51.4 to 61.3
|
52.5 Percentage of participants
Interval 47.3 to 57.7
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 48
|
55.0 Percentage of participants
Interval 49.8 to 60.2
|
52.3 Percentage of participants
Interval 47.1 to 57.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 52
|
55.9 Percentage of participants
Interval 50.6 to 61.1
|
55.6 Percentage of participants
Interval 50.4 to 60.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 56
|
57.1 Percentage of participants
Interval 51.8 to 62.3
|
52.9 Percentage of participants
Interval 47.7 to 58.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 60
|
53.0 Percentage of participants
Interval 47.6 to 58.3
|
53.6 Percentage of participants
Interval 48.3 to 58.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 64
|
58.8 Percentage of participants
Interval 53.5 to 64.2
|
52.9 Percentage of participants
Interval 47.5 to 58.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 68
|
57.0 Percentage of participants
Interval 51.7 to 62.4
|
55.5 Percentage of participants
Interval 50.0 to 60.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 72
|
58.1 Percentage of participants
Interval 52.7 to 63.4
|
53.3 Percentage of participants
Interval 48.0 to 58.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 76
|
58.0 Percentage of participants
Interval 52.6 to 63.4
|
54.0 Percentage of participants
Interval 48.6 to 59.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 80
|
57.3 Percentage of participants
Interval 52.0 to 62.6
|
51.9 Percentage of participants
Interval 46.5 to 57.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 84
|
58.4 Percentage of participants
Interval 53.1 to 63.7
|
56.9 Percentage of participants
Interval 51.5 to 62.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 88
|
57.2 Percentage of participants
Interval 51.9 to 62.6
|
51.1 Percentage of participants
Interval 45.6 to 56.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 92
|
56.1 Percentage of participants
Interval 50.8 to 61.4
|
54.9 Percentage of participants
Interval 49.5 to 60.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 96
|
55.5 Percentage of participants
Interval 49.9 to 61.0
|
53.9 Percentage of participants
Interval 48.4 to 59.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 100
|
55.1 Percentage of participants
Interval 49.5 to 60.7
|
51.7 Percentage of participants
Interval 46.2 to 57.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 104
|
55.1 Percentage of participants
Interval 49.4 to 60.7
|
52.8 Percentage of participants
Interval 47.3 to 58.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 108
|
54.8 Percentage of participants
Interval 49.1 to 60.4
|
51.0 Percentage of participants
Interval 45.5 to 56.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time
Week 112
|
55.7 Percentage of participants
Interval 50.2 to 61.1
|
51.0 Percentage of participants
Interval 45.6 to 56.4
|
SECONDARY outcome
Timeframe: Baseline, average of Weeks 40, 44, and 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Participants with at least one non-missing, valid assessment at Weeks 40, 44, or 48 were included in this analysis.
BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=302 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=291 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48
|
7.9 Percentage of participants
Interval 5.0 to 10.8
|
7.5 Percentage of participants
Interval 4.7 to 10.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 4
|
6.8 Percentage of participants
Interval 4.3 to 9.4
|
6.1 Percentage of participants
Interval 3.7 to 8.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 8
|
7.4 Percentage of participants
Interval 4.8 to 10.1
|
6.2 Percentage of participants
Interval 3.7 to 8.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 12
|
7.6 Percentage of participants
Interval 5.0 to 10.2
|
5.9 Percentage of participants
Interval 3.5 to 8.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 16
|
9.5 Percentage of participants
Interval 6.6 to 12.5
|
5.3 Percentage of participants
Interval 3.0 to 7.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 20
|
9.3 Percentage of participants
Interval 6.4 to 12.3
|
5.7 Percentage of participants
Interval 3.3 to 8.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 24
|
8.1 Percentage of participants
Interval 5.2 to 11.1
|
6.3 Percentage of participants
Interval 3.7 to 8.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 28
|
7.4 Percentage of participants
Interval 4.6 to 10.3
|
6.4 Percentage of participants
Interval 3.7 to 9.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 32
|
8.1 Percentage of participants
Interval 5.1 to 11.0
|
6.6 Percentage of participants
Interval 4.0 to 9.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 36
|
7.8 Percentage of participants
Interval 4.9 to 10.6
|
6.8 Percentage of participants
Interval 4.1 to 9.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 40
|
8.3 Percentage of participants
Interval 5.3 to 11.3
|
7.6 Percentage of participants
Interval 4.8 to 10.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 44
|
7.9 Percentage of participants
Interval 4.9 to 10.9
|
6.8 Percentage of participants
Interval 4.0 to 9.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 48
|
9.7 Percentage of participants
Interval 6.5 to 12.9
|
6.3 Percentage of participants
Interval 3.6 to 9.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 52
|
9.1 Percentage of participants
Interval 6.0 to 12.2
|
6.5 Percentage of participants
Interval 3.7 to 9.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 56
|
8.1 Percentage of participants
Interval 5.1 to 11.1
|
6.3 Percentage of participants
Interval 3.6 to 9.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 60
|
8.2 Percentage of participants
Interval 5.2 to 11.3
|
7.3 Percentage of participants
Interval 4.5 to 10.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 64
|
7.1 Percentage of participants
Interval 4.2 to 10.1
|
7.2 Percentage of participants
Interval 4.3 to 10.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 68
|
8.8 Percentage of participants
Interval 5.6 to 12.0
|
6.8 Percentage of participants
Interval 4.0 to 9.6
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 72
|
8.4 Percentage of participants
Interval 5.2 to 11.6
|
6.2 Percentage of participants
Interval 3.4 to 8.9
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 76
|
9.5 Percentage of participants
Interval 6.2 to 12.9
|
7.4 Percentage of participants
Interval 4.5 to 10.3
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 80
|
9.8 Percentage of participants
Interval 6.5 to 13.1
|
8.4 Percentage of participants
Interval 5.3 to 11.5
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 84
|
9.3 Percentage of participants
Interval 6.0 to 12.6
|
7.2 Percentage of participants
Interval 4.2 to 10.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 88
|
8.4 Percentage of participants
Interval 5.2 to 11.6
|
7.5 Percentage of participants
Interval 4.5 to 10.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 92
|
8.9 Percentage of participants
Interval 5.6 to 12.2
|
9.0 Percentage of participants
Interval 5.8 to 12.2
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 96
|
10.4 Percentage of participants
Interval 6.8 to 13.9
|
9.7 Percentage of participants
Interval 6.5 to 13.0
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 100
|
10.3 Percentage of participants
Interval 6.8 to 13.8
|
10.9 Percentage of participants
Interval 7.5 to 14.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 104
|
9.2 Percentage of participants
Interval 5.8 to 12.6
|
9.8 Percentage of participants
Interval 6.4 to 13.1
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 108
|
9.5 Percentage of participants
Interval 6.0 to 12.9
|
10.0 Percentage of participants
Interval 6.5 to 13.4
|
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time
Week 112
|
9.0 Percentage of participants
Interval 5.7 to 12.4
|
10.6 Percentage of participants
Interval 7.1 to 14.0
|
SECONDARY outcome
Timeframe: Week 48Population: The analysis included all participants randomized to the faricimab arm who completed their Week 48 visit.
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=316 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
Once Every 8 Weeks
|
22.2 Percentage of participants
Interval 17.6 to 26.7
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
Once Every 12 Weeks
|
32.9 Percentage of participants
Interval 27.7 to 38.1
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48
Once Every 16 Weeks
|
44.9 Percentage of participants
Interval 39.4 to 50.4
|
—
|
SECONDARY outcome
Timeframe: Week 60Population: The analysis included all participants randomized to the faricimab arm who completed their Week 60 visit.
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=305 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
Once Every 8 Weeks
|
21.6 Percentage of participants
Interval 17.0 to 26.3
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
Once Every 12 Weeks
|
32.8 Percentage of participants
Interval 27.5 to 38.1
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60
Once Every 16 Weeks
|
45.6 Percentage of participants
Interval 40.0 to 51.2
|
—
|
SECONDARY outcome
Timeframe: Weeks 108 and 112Population: The analysis included all participants randomized to the faricimab arm who completed their Week 112 visit.
Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=287 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Once Every 8 Weeks
|
18.8 Percentage of participants
Interval 14.3 to 23.3
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Once Every 12 Weeks
|
14.3 Percentage of participants
Interval 10.2 to 18.3
|
—
|
|
Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112
Once Every 16 Weeks
|
66.9 Percentage of participants
Interval 61.4 to 72.4
|
—
|
SECONDARY outcome
Timeframe: From Baseline through Week 48Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Number of Study Drug Injections Received in the Study Eye Through Week 48
|
6.0 Injections
Interval 1.0 to 8.0
|
8.0 Injections
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: From Baseline through Week 60Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Number of Study Drug Injections Received in the Study Eye Through Week 60
|
7.0 Injections
Interval 1.0 to 10.0
|
9.0 Injections
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: From Baseline through Week 108Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Number of Study Drug Injections Received in the Study Eye Through Week 108
|
10.0 Injections
Interval 1.0 to 16.0
|
15.0 Injections
Interval 1.0 to 15.0
|
SECONDARY outcome
Timeframe: From Baseline through Week 48Population: 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. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group iteraction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48
|
-137.1 microns
Interval -143.1 to -131.2
|
-130.8 microns
Interval -136.8 to -124.8
|
SECONDARY outcome
Timeframe: From Baseline through Week 60Population: 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. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60
|
-135.7 microns
Interval -141.2 to -130.1
|
-137.0 microns
Interval -142.7 to -131.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, and 112Population: 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. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (\<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 100
|
-145.0 microns
Interval -151.7 to -138.3
|
-146.2 microns
Interval -153.1 to -139.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 4
|
-126.5 microns
Interval -132.3 to -120.6
|
-113.9 microns
Interval -119.8 to -108.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 8
|
-138.0 microns
Interval -143.7 to -132.3
|
-123.8 microns
Interval -129.6 to -118.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 12
|
-141.7 microns
Interval -147.1 to -136.3
|
-129.6 microns
Interval -135.0 to -124.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 16
|
-143.7 microns
Interval -150.3 to -137.1
|
-112.9 microns
Interval -119.6 to -106.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 20
|
-130.9 microns
Interval -136.8 to -125.0
|
-132.9 microns
Interval -138.8 to -126.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 24
|
-130.1 microns
Interval -137.1 to -123.1
|
-112.2 microns
Interval -119.3 to -105.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 28
|
-127.3 microns
Interval -134.0 to -120.6
|
-130.1 microns
Interval -136.9 to -123.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 32
|
-138.6 microns
Interval -145.8 to -131.5
|
-115.3 microns
Interval -122.5 to -108.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 36
|
-124.6 microns
Interval -131.3 to -118.0
|
-135.2 microns
Interval -141.9 to -128.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 40
|
-142.5 microns
Interval -149.3 to -135.6
|
-122.5 microns
Interval -129.4 to -115.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 44
|
-130.9 microns
Interval -136.7 to -125.1
|
-141.6 microns
Interval -147.6 to -135.7
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 48
|
-135.5 microns
Interval -142.3 to -128.6
|
-123.9 microns
Interval -130.8 to -117.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 52
|
-140.9 microns
Interval -146.4 to -135.3
|
-139.6 microns
Interval -145.3 to -134.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 56
|
-138.9 microns
Interval -145.7 to -132.1
|
-125.6 microns
Interval -132.5 to -118.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 60
|
-125.9 microns
Interval -132.0 to -119.7
|
-142.3 microns
Interval -148.6 to -136.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 64
|
-143.8 microns
Interval -150.3 to -137.2
|
-126.0 microns
Interval -132.7 to -119.3
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 68
|
-138.0 microns
Interval -143.9 to -132.2
|
-138.8 microns
Interval -144.8 to -132.8
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 72
|
-140.7 microns
Interval -147.3 to -134.1
|
-128.8 microns
Interval -135.5 to -122.0
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 76
|
-136.1 microns
Interval -142.4 to -129.7
|
-139.0 microns
Interval -145.4 to -132.6
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 80
|
-144.4 microns
Interval -151.1 to -137.8
|
-128.7 microns
Interval -135.5 to -121.9
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 84
|
-143.5 microns
Interval -149.2 to -137.8
|
-143.2 microns
Interval -149.1 to -137.4
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 88
|
-145.5 microns
Interval -151.6 to -139.5
|
-133.3 microns
Interval -139.5 to -127.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 92
|
-142.1 microns
Interval -148.0 to -136.1
|
-143.2 microns
Interval -149.3 to -137.1
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 96
|
-146.8 microns
Interval -153.1 to -140.4
|
-134.7 microns
Interval -141.2 to -128.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 104
|
-149.6 microns
Interval -156.3 to -142.8
|
-137.4 microns
Interval -144.3 to -130.5
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 108
|
-148.5 microns
Interval -154.4 to -142.6
|
-148.3 microns
Interval -154.4 to -142.2
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time
Week 112
|
-152.9 microns
Interval -159.2 to -146.7
|
-139.1 microns
Interval -145.5 to -132.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre \[mm\]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 52
|
85.9 Percentage of participants
Interval 81.9 to 89.8
|
85.3 Percentage of participants
Interval 81.1 to 89.4
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 56
|
85.2 Percentage of participants
Interval 81.1 to 89.2
|
81.1 Percentage of participants
Interval 76.6 to 85.6
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 112
|
85.9 Percentage of participants
Interval 81.8 to 90.0
|
80.5 Percentage of participants
Interval 75.7 to 85.4
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 4
|
86.9 Percentage of participants
Interval 83.5 to 90.4
|
82.9 Percentage of participants
Interval 78.9 to 87.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 8
|
88.5 Percentage of participants
Interval 85.2 to 91.9
|
84.6 Percentage of participants
Interval 80.7 to 88.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 12
|
87.5 Percentage of participants
Interval 84.0 to 91.0
|
84.5 Percentage of participants
Interval 80.6 to 88.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 16
|
90.6 Percentage of participants
Interval 87.5 to 93.7
|
76.5 Percentage of participants
Interval 71.9 to 81.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 20
|
78.8 Percentage of participants
Interval 74.5 to 83.0
|
86.1 Percentage of participants
Interval 82.3 to 89.8
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 24
|
78.7 Percentage of participants
Interval 74.2 to 83.1
|
78.0 Percentage of participants
Interval 73.4 to 82.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 28
|
77.1 Percentage of participants
Interval 72.4 to 81.8
|
85.9 Percentage of participants
Interval 81.8 to 89.9
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 32
|
86.3 Percentage of participants
Interval 82.5 to 90.2
|
78.3 Percentage of participants
Interval 73.6 to 82.9
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 36
|
79.6 Percentage of participants
Interval 75.0 to 84.1
|
86.1 Percentage of participants
Interval 82.1 to 90.1
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 40
|
84.5 Percentage of participants
Interval 80.3 to 88.7
|
77.5 Percentage of participants
Interval 72.7 to 82.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 44
|
78.5 Percentage of participants
Interval 73.7 to 83.2
|
84.2 Percentage of participants
Interval 79.9 to 88.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 48
|
84.1 Percentage of participants
Interval 79.8 to 88.4
|
77.7 Percentage of participants
Interval 72.8 to 82.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 60
|
77.8 Percentage of participants
Interval 73.0 to 82.6
|
85.4 Percentage of participants
Interval 81.2 to 89.5
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 104
|
86.0 Percentage of participants
Interval 81.9 to 90.1
|
80.0 Percentage of participants
Interval 75.1 to 84.9
|
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time
Week 108
|
82.2 Percentage of participants
Interval 77.7 to 86.6
|
83.5 Percentage of participants
Interval 79.0 to 88.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 40
|
77.6 Percentage of participants
Interval 72.9 to 82.3
|
63.9 Percentage of participants
Interval 58.4 to 69.5
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 52
|
83.0 Percentage of participants
Interval 78.8 to 87.3
|
80.6 Percentage of participants
Interval 76.0 to 85.3
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 60
|
63.6 Percentage of participants
Interval 58.1 to 69.0
|
80.0 Percentage of participants
Interval 75.3 to 84.8
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 104
|
80.0 Percentage of participants
Interval 75.3 to 84.7
|
73.9 Percentage of participants
Interval 68.5 to 79.3
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 4
|
70.9 Percentage of participants
Interval 66.1 to 75.7
|
61.7 Percentage of participants
Interval 56.4 to 66.9
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 8
|
79.8 Percentage of participants
Interval 75.6 to 84.1
|
73.6 Percentage of participants
Interval 68.9 to 78.4
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 12
|
88.6 Percentage of participants
Interval 85.1 to 92.0
|
79.6 Percentage of participants
Interval 75.3 to 84.0
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 16
|
90.6 Percentage of participants
Interval 87.4 to 93.8
|
63.8 Percentage of participants
Interval 58.6 to 68.9
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 20
|
76.1 Percentage of participants
Interval 71.6 to 80.7
|
80.4 Percentage of participants
Interval 76.1 to 84.8
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 24
|
73.7 Percentage of participants
Interval 68.8 to 78.5
|
59.1 Percentage of participants
Interval 53.5 to 64.6
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 28
|
71.5 Percentage of participants
Interval 66.6 to 76.4
|
78.7 Percentage of participants
Interval 73.9 to 83.5
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 32
|
82.6 Percentage of participants
Interval 78.3 to 87.0
|
62.2 Percentage of participants
Interval 56.7 to 67.7
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 36
|
70.6 Percentage of participants
Interval 65.5 to 75.7
|
80.7 Percentage of participants
Interval 76.1 to 85.2
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 44
|
65.7 Percentage of participants
Interval 60.3 to 71.0
|
76.2 Percentage of participants
Interval 71.1 to 81.2
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 48
|
72.5 Percentage of participants
Interval 67.5 to 77.5
|
62.1 Percentage of participants
Interval 56.5 to 67.7
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 56
|
80.7 Percentage of participants
Interval 76.3 to 85.2
|
71.6 Percentage of participants
Interval 66.4 to 76.8
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 108
|
76.1 Percentage of participants
Interval 71.2 to 81.0
|
80.7 Percentage of participants
Interval 75.8 to 85.5
|
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time
Week 112
|
80.9 Percentage of participants
Interval 76.4 to 85.4
|
77.5 Percentage of participants
Interval 72.4 to 82.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of intraretinal and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 4
|
59.5 Percentage of participants
Interval 54.2 to 64.8
|
49.8 Percentage of participants
Interval 44.4 to 55.2
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 8
|
70.2 Percentage of participants
Interval 65.2 to 75.1
|
61.6 Percentage of participants
Interval 56.3 to 66.9
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 12
|
77.0 Percentage of participants
Interval 72.4 to 81.5
|
66.6 Percentage of participants
Interval 61.5 to 71.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 44
|
49.5 Percentage of participants
Interval 43.7 to 55.3
|
64.3 Percentage of participants
Interval 58.5 to 70.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 16
|
82.4 Percentage of participants
Interval 78.3 to 86.5
|
47.6 Percentage of participants
Interval 42.2 to 53.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 20
|
62.3 Percentage of participants
Interval 57.3 to 67.4
|
68.6 Percentage of participants
Interval 63.6 to 73.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 24
|
56.5 Percentage of participants
Interval 50.8 to 62.1
|
45.4 Percentage of participants
Interval 39.7 to 51.1
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 28
|
55.5 Percentage of participants
Interval 49.9 to 61.1
|
66.5 Percentage of participants
Interval 61.0 to 72.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 32
|
73.1 Percentage of participants
Interval 68.0 to 78.1
|
48.6 Percentage of participants
Interval 42.9 to 54.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 36
|
56.3 Percentage of participants
Interval 50.8 to 61.9
|
68.3 Percentage of participants
Interval 62.9 to 73.7
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 40
|
65.8 Percentage of participants
Interval 60.3 to 71.2
|
49.0 Percentage of participants
Interval 43.2 to 54.8
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 48
|
62.2 Percentage of participants
Interval 56.6 to 67.8
|
46.1 Percentage of participants
Interval 40.3 to 52.0
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 52
|
70.3 Percentage of participants
Interval 65.2 to 75.5
|
68.8 Percentage of participants
Interval 63.4 to 74.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 56
|
66.9 Percentage of participants
Interval 61.5 to 72.3
|
57.5 Percentage of participants
Interval 51.8 to 63.3
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 60
|
49.3 Percentage of participants
Interval 43.5 to 55.0
|
69.1 Percentage of participants
Interval 63.6 to 74.6
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 104
|
68.1 Percentage of participants
Interval 62.5 to 73.7
|
58.6 Percentage of participants
Interval 52.7 to 64.6
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 108
|
61.6 Percentage of participants
Interval 55.9 to 67.3
|
67.1 Percentage of participants
Interval 61.3 to 72.9
|
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time
Week 112
|
68.7 Percentage of participants
Interval 63.3 to 74.1
|
61.1 Percentage of participants
Interval 55.1 to 67.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. At a given timepoint, the number analyzed includes participants with a non-missing, valid assessment at that timepoint.
Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and \<33 letters), and region (U.S. and Canada vs. rest of the world). Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.03% CI.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=327 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 48
|
3.3 Percentage of participants
Interval 1.2 to 5.3
|
6.5 Percentage of participants
Interval 3.7 to 9.3
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 56
|
4.7 Percentage of participants
Interval 2.3 to 7.2
|
5.2 Percentage of participants
Interval 2.7 to 7.7
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 4
|
3.7 Percentage of participants
Interval 1.7 to 5.8
|
5.6 Percentage of participants
Interval 3.1 to 8.1
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 8
|
3.1 Percentage of participants
Interval 1.3 to 5.0
|
4.1 Percentage of participants
Interval 1.9 to 6.2
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 12
|
4.7 Percentage of participants
Interval 2.4 to 7.0
|
5.5 Percentage of participants
Interval 3.0 to 8.0
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 16
|
2.5 Percentage of participants
Interval 0.8 to 4.1
|
5.8 Percentage of participants
Interval 3.2 to 8.4
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 20
|
3.8 Percentage of participants
Interval 1.7 to 5.9
|
6.0 Percentage of participants
Interval 3.4 to 8.6
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 24
|
4.1 Percentage of participants
Interval 1.8 to 6.3
|
4.9 Percentage of participants
Interval 2.5 to 7.4
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 28
|
2.6 Percentage of participants
Interval 0.9 to 4.4
|
1.9 Percentage of participants
Interval 0.3 to 3.5
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 32
|
4.3 Percentage of participants
Interval 2.0 to 6.6
|
1.8 Percentage of participants
Interval 0.3 to 3.3
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 36
|
4.8 Percentage of participants
Interval 2.4 to 7.1
|
3.9 Percentage of participants
Interval 1.7 to 6.1
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 40
|
6.3 Percentage of participants
Interval 3.5 to 9.0
|
7.3 Percentage of participants
Interval 4.4 to 10.3
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 44
|
3.9 Percentage of participants
Interval 1.7 to 6.2
|
9.1 Percentage of participants
Interval 5.9 to 12.4
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 52
|
5.8 Percentage of participants
Interval 3.1 to 8.5
|
8.1 Percentage of participants
Interval 5.0 to 11.3
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 60
|
3.5 Percentage of participants
Interval 1.4 to 5.6
|
6.3 Percentage of participants
Interval 3.4 to 9.1
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 104
|
8.0 Percentage of participants
Interval 4.8 to 11.2
|
8.3 Percentage of participants
Interval 5.0 to 11.7
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 108
|
6.9 Percentage of participants
Interval 3.9 to 10.0
|
8.0 Percentage of participants
Interval 4.7 to 11.2
|
|
Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time
Week 112
|
8.1 Percentage of participants
Interval 4.9 to 11.3
|
12.5 Percentage of participants
Interval 8.4 to 16.5
|
SECONDARY outcome
Timeframe: Up to 112 weeksPopulation: The percentage of participants with absence of intraretinal cysts over time was planned but it was not evaluated (i.e., 0 participants analyzed) because the absence of intraretinal fluid and the absence of intraretinal cysts are described by the same variable during reading center grading.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 48 were included in this analysis.
The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Outcome measures
| Measure |
Arm A: Faricimab
n=240 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=236 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48
|
0.3 millimetres squared (mm^2)
Standard Deviation 4.6
|
1.1 millimetres squared (mm^2)
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline and Week 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 112 were included in this analysis.
The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Outcome measures
| Measure |
Arm A: Faricimab
n=240 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=224 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112
|
1.7 millimetres squared (mm^2)
Standard Deviation 7.5
|
1.7 millimetres squared (mm^2)
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 48 were included in this analysis.
The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Outcome measures
| Measure |
Arm A: Faricimab
n=241 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=238 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48
|
-3.3 millimetres squared (mm^2)
Standard Deviation 6.6
|
-2.1 millimetres squared (mm^2)
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline and Week 112Population: ITT Population: all participants who were randomized in the study, grouped according to the treatment assigned at randomization. Only participants with non-missing, valid assessments at Baseline and Week 112 were included in this analysis.
The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.
Outcome measures
| Measure |
Arm A: Faricimab
n=239 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=220 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112
|
-5.3 millimetres squared (mm^2)
Standard Deviation 7.2
|
-4.2 millimetres squared (mm^2)
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 112 weeks)Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With at Least One Adverse Event
Adverse Event (AE)
|
84.9 Percentage of participants
|
88.0 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
Serious AE (SAE)
|
27.5 Percentage of participants
|
31.0 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
AE Leading to Withdrawal from Study Treatment
|
4.8 Percentage of participants
|
2.8 Percentage of participants
|
|
Percentage of Participants With at Least One Adverse Event
AE of Special Interest (AESI)
|
7.3 Percentage of participants
|
6.1 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 112 weeks)Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Multiple occurrences of the same AE in one individual are counted only once. 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
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Serious AE (SAE)
|
4.5 Percentage of participants
|
4.9 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AE Leading to Withdrawal from Treatment
|
3.3 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Adverse Event (AE)
|
52.9 Percentage of participants
|
47.5 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Treatment-related AE
|
3.6 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Treatment-related SAE
|
1.8 Percentage of participants
|
0.6 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AE of Special Interest (AESI)
|
3.9 Percentage of participants
|
4.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Drop in VA Score ≥30 Letters
|
2.7 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Associated with Severe IOI
|
0.6 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss
|
0.6 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Study Eye: Suspected Transmission of Infectious Agent by Study Drug
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AE
|
46.2 Percentage of participants
|
41.7 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: SAE
|
3.6 Percentage of participants
|
2.5 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI
|
3.0 Percentage of participants
|
2.1 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI, Drop in VA Score ≥30 Letters
|
2.1 Percentage of participants
|
1.8 Percentage of participants
|
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Fellow Eye: AESI, Intervention Req. to Prevent Permanent Vision Loss
|
0.9 Percentage of participants
|
0.3 Percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of study drug through end of study (up to 112 weeks)Population: Safety Evaluable Population: all participants who received at least one dose of active study drug (faricimab or aflibercept) in the study eye.
This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. 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. 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
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 Participants
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
Serious AE (SAE)
|
21.8 Percentage of participants
|
26.4 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
Adverse Event (AE)
|
71.0 Percentage of participants
|
75.8 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
AE Leading to Withdrawal from Study Treatment
|
1.5 Percentage of participants
|
0.9 Percentage of participants
|
|
Percentage of Participants With at Least One Non-Ocular Adverse Event
AE of Special Interest (AESI)
|
0.3 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112Population: This analysis only includes Arm A participants who received treatment with faricimab in the pharmacokinetic-evaluable population, which includes safety-evaluable participants with at least one plasma sample, provided sufficient dosing information (dose and dosing time) was available. The number of participants analyzed at a given timepoint includes those with an available plasma sample and dosing information at that timepoint.
Faricimab concentration in plasma was determined using a validated immunoassay method.
Outcome measures
| Measure |
Arm A: Faricimab
n=331 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Plasma Concentration of Faricimab Over Time
Baseline
|
0.0000 micrograms per millilitre (μg/mL)
Standard Deviation 0.0001
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 4
|
0.0287 micrograms per millilitre (μg/mL)
Standard Deviation 0.0209
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 16
|
0.0333 micrograms per millilitre (μg/mL)
Standard Deviation 0.0250
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 20
|
0.0046 micrograms per millilitre (μg/mL)
Standard Deviation 0.0051
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 48
|
0.0149 micrograms per millilitre (μg/mL)
Standard Deviation 0.0185
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 76
|
0.0053 micrograms per millilitre (μg/mL)
Standard Deviation 0.0117
|
—
|
|
Plasma Concentration of Faricimab Over Time
Week 112
|
0.0119 micrograms per millilitre (μg/mL)
Standard Deviation 0.0149
|
—
|
SECONDARY outcome
Timeframe: Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112Population: The immunogenicity-analysis population includes all participants randomized to the faricimab arm with at least one determinant ADA assessment. Only those with at least one post-baseline ADA assessment were included in this analysis.
Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.
Outcome measures
| Measure |
Arm A: Faricimab
n=330 Participants
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Total Treatment-Emergent ADA-Positive
|
16.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Treatment-Induced ADA-Positive
|
16.1 Percentage of participants
|
—
|
|
Percentage of Participants Who Tested Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Treatment-Boosted ADA-Positive
|
0.0 Percentage of participants
|
—
|
Adverse Events
Arm A: Faricimab
Serious events: 91 serious events
Other events: 178 other events
Deaths: 10 deaths
Arm B: Aflibercept
Serious events: 101 serious events
Other events: 165 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Arm A: Faricimab
n=331 participants at risk
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 participants at risk
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Angina pectoris
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Atrial fibrillation
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.8%
6/326 • Number of events 11 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Dressler's syndrome
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Pericardial effusion
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Pericarditis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Angle closure glaucoma
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Eye allergy
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Macular degeneration
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
2.4%
8/331 • Number of events 8 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.2%
4/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal vein occlusion
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Uveitis
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous haemorrhage
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitritis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Adverse drug reaction
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Death
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Ill-defined disorder
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Pain
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.2%
4/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Cellulitis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Chorioretinitis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Diverticulitis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Endophthalmitis
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Influenza
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Osteomyelitis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pneumonia
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.8%
6/326 • Number of events 7 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Sepsis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.5%
5/326 • Number of events 5 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Viral uveitis
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fall
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Intraocular pressure increased
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Investigations
Weight decreased
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
4/331 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcomatoid carcinoma
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcomatoid carcinoma of the lung
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Brain oedema
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.5%
5/326 • Number of events 9 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Postictal paralysis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Presyncope
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Seizure
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Syncope
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Product Issues
Device malfunction
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.91%
3/331 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
1.2%
4/326 • Number of events 4 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Lung perforation
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertension
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Orthostatic hypotension
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Age-related macular degeneration
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Corneal opacity
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Diplopia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Non-infectious endophthalmitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Peripheral exudative haemorrhagic chorioretinopathy
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Retinal tear
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Visual acuity reduced
|
0.30%
1/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Food poisoning
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Gastric dysplasia
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Asthenia
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
General disorders
Chest pain
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
2/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
2.1%
7/326 • Number of events 7 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Cataract traumatic
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage IV
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.61%
2/326 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Dementia
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Renal and urinary disorders
Renal colic
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.30%
1/331 • Number of events 2 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.92%
3/326 • Number of events 3 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Haematoma
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Peripheral ischaemia
|
0.30%
1/331 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.00%
0/326 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/331 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
0.31%
1/326 • Number of events 1 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
Other adverse events
| Measure |
Arm A: Faricimab
n=331 participants at risk
Participants randomized to Arm A received 6 mg of faricimab intravitreally (IVT) once every 4 weeks (Q4W) up to Week 12 (4 injections). At Week 20, protocol-defined assessment of disease activity required Arm A participants with active disease to be treated with a once every 8 weeks (Q8W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 20, 28, 36, 44, 52, and 60). A second protocol-defined assessment of disease activity at Week 24 required Arm A participants with active disease (excluding those with active disease at Week 20) to be treated with a once every 12 weeks (Q12W) dosing regimen of 6 mg of faricimab IVT (i.e., injections at Weeks 24, 36, 48, and 60). Participants receiving faricimab who did not have active disease according to the protocol-defined criteria at Week 20 and Week 24 were treated with 6 mg of faricimab IVT once every 16 weeks (Q16W) (i.e., injections at Weeks 28, 44, and 60). From Week 60 (when all Arm A participants were scheduled to receive study drug) to Week 108, Arm A participants were to be treated according to a personalized treatment interval (PTI) dosing regimen (Q8W, Q12W, or Q16W).
|
Arm B: Aflibercept
n=326 participants at risk
Participants randomized to the active comparator (Arm B) received a 2-mg dose of aflibercept that was administered intravitreally (IVT) Q8W, after 3 consecutive monthly doses during the 108-week treatment period. Participants were to receive 15 IVT injections of aflibercept during the 108-week treatment period comprising three initiating injections (2 mg of aflibercept Q4W to Week 8), followed by 12 maintenance injections (2 mg of aflibercept Q8W at Weeks 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, and 104).
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
10.6%
35/331 • Number of events 47 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
11.3%
37/326 • Number of events 72 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
24.2%
80/331 • Number of events 103 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
19.0%
62/326 • Number of events 81 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Nasopharyngitis
|
8.2%
27/331 • Number of events 33 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
6.7%
22/326 • Number of events 25 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Cataract
|
11.5%
38/331 • Number of events 55 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.0%
26/326 • Number of events 38 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Dry eye
|
4.5%
15/331 • Number of events 27 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
6.4%
21/326 • Number of events 37 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Posterior capsule opacification
|
4.5%
15/331 • Number of events 20 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.8%
19/326 • Number of events 23 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Eye disorders
Vitreous detachment
|
6.6%
22/331 • Number of events 29 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
6.4%
21/326 • Number of events 26 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Infections and infestations
Urinary tract infection
|
5.7%
19/331 • Number of events 23 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
8.9%
29/326 • Number of events 36 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Injury, poisoning and procedural complications
Fall
|
5.4%
18/331 • Number of events 20 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
6.7%
22/326 • Number of events 27 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
|
Vascular disorders
Hypertension
|
4.5%
15/331 • Number of events 15 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
5.5%
18/326 • Number of events 18 • From first dose of study drug through end of study (up to 112 weeks)
Adverse events (AEs) are reported for the safety population, which includes all participants who received at least one injection of active study drug (faricimab or aflibercept) in the study eye. For ocular AEs, the number of participants and events reported per term are combined totals of AEs that occurred in the study eye or the fellow eye.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER