Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI. |
From Baseline through Week 24 |
|
| Secondary |
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
From Baseline through Week 24 |
|
| Secondary |
Part 1: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24 |
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and =38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24 |
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the Bruch's membrane (BM) using optical coherence tomography (OCT), as assessed by the central reading center. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24 |
Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24 |
Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (=55, <55->34, and =34 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI. |
Baseline, Weeks 4, 8, 12, 16, 20, and 24 |
|
| Secondary |
Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24 |
The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (=55 and =54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI. |
Baseline and Week 24 |
|
| Secondary |
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Gaining =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Gaining =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Gaining =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Achieving =84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants Achieving =69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants With =38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72 |
|
Baseline, Weeks 24, 48, and 72 |
|
| Secondary |
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72 |
|
Baseline and every 4 weeks from Week 4 to Week 72 |
|
| Secondary |
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 24 to Week 72 |
|
| Secondary |
Part 2: Percentage of Participants Avoiding a Loss of =15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 24 to Week 72 |
|
| Secondary |
Part 2: Percentage of Participants Avoiding a Loss of =10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 24 to Week 72 |
|
| Secondary |
Part 2: Percentage of Participants Avoiding a Loss of =5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 24 to Week 72 |
|
| Secondary |
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72 |
|
Every 4 weeks from Week 24 to Week 72 |
|
| Secondary |
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68 |
|
Week 68 |
|
| Secondary |
Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72 |
|
From Week 24 to Week 72 |
|
| Secondary |
Incidence and Severity of Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale |
|
From Baseline until end of study (up to 72 weeks) |
|
| Secondary |
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale |
|
From Baseline until end of study (up to 72 weeks) |
|
| Secondary |
Plasma Concentration of Faricimab Over Time |
|
Predose at Day 1, Weeks 4, 24, 28, 52, and 72 |
|
| Secondary |
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study |
|
Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72 |
|
