18 and older, any sex, with Macular Edema or Central Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24Primary· From Baseline 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 (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the w
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
16.9
15.4 – 18.3
Arm B: Aflibercept Q4W (Part 1)
17.3
15.9 – 18.8
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the w
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
13.5
12.5 – 14.6
Arm B: Aflibercept Q4W (Part 1)
14.3
13.2 – 15.4
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
15.5
14.4 – 16.7
Arm B: Aflibercept Q4W (Part 1)
16.5
15.3 – 17.7
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
16.9
15.7 – 18.2
Arm B: Aflibercept Q4W (Part 1)
17.1
15.8 – 18.4
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
16.8
15.4 – 18.1
Arm B: Aflibercept Q4W (Part 1)
17.5
16.2 – 18.9
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
17.0
15.6 – 18.3
Arm B: Aflibercept Q4W (Part 1)
17.2
15.8 – 18.5
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
16.9
15.4 – 18.3
Arm B: Aflibercept Q4W (Part 1)
17.3
15.9 – 18.8
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24Secondary· From Baseline 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
56.6
51.7 – 61.5
Arm B: Aflibercept Q4W (Part 1)
58.1
53.3 – 62.9
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
41.5
36.7 – 46.3
Arm B: Aflibercept Q4W (Part 1)
45.4
40.7 – 50.2
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
51.1
46.3 – 55.9
Arm B: Aflibercept Q4W (Part 1)
53.7
48.9 – 58.5
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
54.6
49.8 – 59.4
Arm B: Aflibercept Q4W (Part 1)
55.1
50.3 – 59.9
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
57.7
52.8 – 62.5
Arm B: Aflibercept Q4W (Part 1)
59.5
54.7 – 64.3
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
56.6
51.7 – 61.4
Arm B: Aflibercept Q4W (Part 1)
57.8
53.0 – 62.6
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
56.6
51.7 – 61.5
Arm B: Aflibercept Q4W (Part 1)
58.1
53.3 – 62.9
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
60.9
56.0 – 65.8
Arm B: Aflibercept Q4W (Part 1)
62.3
57.6 – 66.9
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
69.1
64.5 – 73.7
Arm B: Aflibercept Q4W (Part 1)
72.8
68.3 – 77.2
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
73.2
68.8 – 77.7
Arm B: Aflibercept Q4W (Part 1)
74.7
70.3 – 79.0
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
73.5
69.1 – 78.0
Arm B: Aflibercept Q4W (Part 1)
75.8
71.4 – 80.1
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
72.4
68.0 – 76.9
Arm B: Aflibercept Q4W (Part 1)
74.1
69.7 – 78.5
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
72.2
67.7 – 76.6
Arm B: Aflibercept Q4W (Part 1)
73.3
68.8 – 77.7
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
83.1
79.3 – 86.9
Arm B: Aflibercept Q4W (Part 1)
83.5
79.7 – 87.2
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
85.2
81.7 – 88.8
Arm B: Aflibercept Q4W (Part 1)
86.8
83.3 – 90.2
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
87.4
84.1 – 90.8
Arm B: Aflibercept Q4W (Part 1)
87.1
83.7 – 90.5
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
86.3
82.9 – 89.8
Arm B: Aflibercept Q4W (Part 1)
88.7
85.5 – 92.0
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
84.1
80.5 – 87.8
Arm B: Aflibercept Q4W (Part 1)
86.5
83.0 – 90.0
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
85.3
81.8 – 88.8
Arm B: Aflibercept Q4W (Part 1)
84.6
80.9 – 88.2
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
92.1
89.4 – 94.8
Arm B: Aflibercept Q4W (Part 1)
95.6
93.5 – 97.7
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
92.1
89.4 – 94.8
Arm B: Aflibercept Q4W (Part 1)
94.8
92.5 – 97.0
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
93.2
90.6 – 95.7
Arm B: Aflibercept Q4W (Part 1)
92.6
89.9 – 95.2
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
92.6
90.0 – 95.3
Arm B: Aflibercept Q4W (Part 1)
92.0
89.3 – 94.8
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
90.5
87.5 – 93.4
Arm B: Aflibercept Q4W (Part 1)
91.4
88.6 – 94.3
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
90.5
87.5 – 93.4
Arm B: Aflibercept Q4W (Part 1)
89.2
86.1 – 92.4
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
98.4
97.1 – 99.7
Arm B: Aflibercept Q4W (Part 1)
98.9
97.8 – 100.0
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
98.1
96.7 – 99.5
Arm B: Aflibercept Q4W (Part 1)
98.1
96.7 – 99.5
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
98.6
97.5 – 99.8
Arm B: Aflibercept Q4W (Part 1)
97.5
95.9 – 99.1
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
97.3
95.6 – 98.9
Arm B: Aflibercept Q4W (Part 1)
97.0
95.2 – 98.7
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
97.0
95.3 – 98.7
Arm B: Aflibercept Q4W (Part 1)
96.7
94.9 – 98.5
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
96.2
94.3 – 98.1
Arm B: Aflibercept Q4W (Part 1)
96.7
94.9 – 98.5
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
98.1
96.7 – 99.5
Arm B: Aflibercept Q4W (Part 1)
98.6
97.4 – 99.8
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
97.5
96.0 – 99.1
Arm B: Aflibercept Q4W (Part 1)
97.5
95.9 – 99.1
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
97.8
96.3 – 99.3
Arm B: Aflibercept Q4W (Part 1)
97.0
95.2 – 98.7
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
95.9
93.9 – 97.9
Arm B: Aflibercept Q4W (Part 1)
96.1
94.2 – 98.1
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
96.7
94.9 – 98.5
Arm B: Aflibercept Q4W (Part 1)
96.1
94.2 – 98.1
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
95.1
92.9 – 97.3
Arm B: Aflibercept Q4W (Part 1)
95.9
93.8 – 97.9
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
97.0
95.3 – 98.7
Arm B: Aflibercept Q4W (Part 1)
98.1
96.7 – 99.5
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
96.2
94.2 – 98.1
Arm B: Aflibercept Q4W (Part 1)
96.4
94.5 – 98.3
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
95.9
93.9 – 97.9
Arm B: Aflibercept Q4W (Part 1)
96.1
94.2 – 98.1
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
95.4
93.2 – 97.5
Arm B: Aflibercept Q4W (Part 1)
94.8
92.5 – 97.0
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
94.8
92.6 – 97.1
Arm B: Aflibercept Q4W (Part 1)
93.9
91.5 – 96.4
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
94.0
91.6 – 96.4
Arm B: Aflibercept Q4W (Part 1)
93.7
91.2 – 96.1
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
6.0
3.6 – 8.4
Arm B: Aflibercept Q4W (Part 1)
4.7
2.6 – 6.8
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
8.7
5.9 – 11.5
Arm B: Aflibercept Q4W (Part 1)
10.2
7.2 – 13.2
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
10.9
7.8 – 14.0
Arm B: Aflibercept Q4W (Part 1)
11.9
8.7 – 15.0
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
11.5
8.4 – 14.6
Arm B: Aflibercept Q4W (Part 1)
14.1
10.7 – 17.5
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
14.2
10.9 – 17.6
Arm B: Aflibercept Q4W (Part 1)
14.9
11.4 – 18.3
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
14.5
11.0 – 17.9
Arm B: Aflibercept Q4W (Part 1)
15.2
11.7 – 18.7
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24Secondary· Baseline, Weeks 4, 8, 12, 16, 20, and 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 \[baseline BCVA (≤34, 35-54, and ≥55 letters), and region (U.S. and Canada, Asia, and rest of the world)\]. All observed values were used regardless of the occurr
Week 4
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
45.0
41.0 – 49.1
Arm B: Aflibercept Q4W (Part 1)
46.1
41.9 – 50.2
Week 8
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
48.6
44.3 – 52.8
Arm B: Aflibercept Q4W (Part 1)
54.6
50.5 – 58.7
Week 12
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
54.9
50.8 – 58.9
Arm B: Aflibercept Q4W (Part 1)
55.7
51.4 – 60.0
Week 16
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
54.9
50.6 – 59.1
Arm B: Aflibercept Q4W (Part 1)
59.3
55.2 – 63.4
Week 20
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
54.1
49.7 – 58.4
Arm B: Aflibercept Q4W (Part 1)
57.6
53.4 – 61.8
Week 24
Group
Value
95% CI
Arm A: Faricimab Q4W (Part 1)
55.7
51.3 – 60.0
Arm B: Aflibercept Q4W (Part 1)
59.0
54.5 – 63.4
Adverse events — posted to ClinicalTrials.gov
Time frame: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07425522 — A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With D
· Phase 1
· recruiting
NCT07520045 — Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
· NA
· recruiting
NCT07088445 — Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration
· not yet recruiting
NCT06908876 — A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
· Phase 2
· recruiting
NCT06795048 — A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macu
· Phase 4
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 6 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04740931.