50 and older, any sex, with Wet Macular Degeneration. 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.
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48Primary· From Baseline through Week 48
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 covarianc
Group
Value
95% CI
Arm A: Faricimab
5.8
4.6 – 7.1
Arm B: Aflibercept
5.1
3.9 – 6.4
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60Secondary· From Baseline through Week 60
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 covarianc
Group
Value
95% CI
Arm A: Faricimab
5.4
4.0 – 6.8
Arm B: Aflibercept
4.6
3.3 – 6.0
Change From Baseline in BCVA in the Study Eye Over TimeSecondary· 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 112
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 covarianc
Week 4
Group
Value
95% CI
Arm A: Faricimab
4.0
3.2 – 4.8
Arm B: Aflibercept
3.6
2.8 – 4.4
Week 8
Group
Value
95% CI
Arm A: Faricimab
5.5
4.6 – 6.4
Arm B: Aflibercept
4.5
3.6 – 5.4
Week 12
Group
Value
95% CI
Arm A: Faricimab
6.4
5.5 – 7.4
Arm B: Aflibercept
5.3
4.4 – 6.2
Week 16
Group
Value
95% CI
Arm A: Faricimab
6.8
5.8 – 7.8
Arm B: Aflibercept
5.2
4.2 – 6.2
Week 20
Group
Value
95% CI
Arm A: Faricimab
6.6
5.5 – 7.6
Arm B: Aflibercept
4.9
3.9 – 6.0
Week 24
Group
Value
95% CI
Arm A: Faricimab
6.4
5.2 – 7.5
Arm B: Aflibercept
5.1
4.0 – 6.3
Week 28
Group
Value
95% CI
Arm A: Faricimab
6.2
5.1 – 7.3
Arm B: Aflibercept
5.6
4.5 – 6.7
Week 32
Group
Value
95% CI
Arm A: Faricimab
6.2
4.9 – 7.4
Arm B: Aflibercept
5.1
3.8 – 6.3
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 48Secondary· Baseline, average of Weeks 40, 44, and 48
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,
Gaining ≥15 Letters
Group
Value
95% CI
Arm A: Faricimab
20.0
15.6 – 24.4
Arm B: Aflibercept
15.7
11.9 – 19.6
Gaining ≥10 Letters
Group
Value
95% CI
Arm A: Faricimab
37.1
31.7 – 42.4
Arm B: Aflibercept
31.7
26.7 – 36.8
Gaining ≥5 Letters
Group
Value
95% CI
Arm A: Faricimab
59.2
53.7 – 64.7
Arm B: Aflibercept
58.0
52.6 – 63.5
Gaining ≥0 Letters
Group
Value
95% CI
Arm A: Faricimab
75.6
70.8 – 80.3
Arm B: Aflibercept
76.8
72.1 – 81.4
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60Secondary· Baseline, average of Weeks 52, 56, and 60
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,
Group
Value
95% CI
Arm A: Faricimab
19.2
15.0 – 23.5
Arm B: Aflibercept
16.6
12.5 – 20.6
Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Over TimeSecondary· 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 112
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 combine
Week 4
Group
Value
95% CI
Arm A: Faricimab
10.1
6.9 – 13.2
Arm B: Aflibercept
6.3
3.8 – 8.8
Week 8
Group
Value
95% CI
Arm A: Faricimab
13.7
10.1 – 17.3
Arm B: Aflibercept
8.1
5.3 – 10.9
Week 12
Group
Value
95% CI
Arm A: Faricimab
16.7
12.8 – 20.5
Arm B: Aflibercept
10.1
7.0 – 13.1
Week 16
Group
Value
95% CI
Arm A: Faricimab
17.7
13.7 – 21.6
Arm B: Aflibercept
13.4
10.0 – 16.9
Week 20
Group
Value
95% CI
Arm A: Faricimab
19.1
14.9 – 23.2
Arm B: Aflibercept
12.7
9.1 – 16.2
Week 24
Group
Value
95% CI
Arm A: Faricimab
22.1
17.4 – 26.7
Arm B: Aflibercept
13.3
9.6 – 17.0
Week 28
Group
Value
95% CI
Arm A: Faricimab
20.8
16.4 – 25.2
Arm B: Aflibercept
16.2
12.1 – 20.3
Week 32
Group
Value
95% CI
Arm A: Faricimab
21.6
17.0 – 26.1
Arm B: Aflibercept
15.1
11.3 – 18.9
Percentage of Participants Gaining ≥10 Letters From the Baseline BCVA in the Study Eye Over TimeSecondary· 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 112
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 combine
Week 4
Group
Value
95% CI
Arm A: Faricimab
20.1
16.0 – 24.2
Arm B: Aflibercept
16.0
12.3 – 19.7
Week 8
Group
Value
95% CI
Arm A: Faricimab
28.6
23.9 – 33.3
Arm B: Aflibercept
25.3
20.9 – 29.8
Week 12
Group
Value
95% CI
Arm A: Faricimab
31.4
26.5 – 36.3
Arm B: Aflibercept
30.3
25.5 – 35.1
Week 16
Group
Value
95% CI
Arm A: Faricimab
36.9
31.8 – 41.9
Arm B: Aflibercept
31.9
27.0 – 36.7
Week 20
Group
Value
95% CI
Arm A: Faricimab
39.1
34.0 – 44.2
Arm B: Aflibercept
30.3
25.4 – 35.2
Week 24
Group
Value
95% CI
Arm A: Faricimab
41.4
36.0 – 46.9
Arm B: Aflibercept
34.0
28.7 – 39.3
Week 28
Group
Value
95% CI
Arm A: Faricimab
38.9
33.5 – 44.3
Arm B: Aflibercept
34.8
29.5 – 40.1
Week 32
Group
Value
95% CI
Arm A: Faricimab
38.6
33.2 – 44.0
Arm B: Aflibercept
32.4
27.2 – 37.7
Percentage of Participants Gaining ≥5 Letters From the Baseline BCVA in the Study Eye Over TimeSecondary· 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 112
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 combine
Week 4
Group
Value
95% CI
Arm A: Faricimab
47.6
42.3 – 52.8
Arm B: Aflibercept
45.6
40.4 – 50.9
Week 8
Group
Value
95% CI
Arm A: Faricimab
57.8
52.5 – 63.0
Arm B: Aflibercept
52.3
47.2 – 57.5
Week 12
Group
Value
95% CI
Arm A: Faricimab
61.5
56.3 – 66.8
Arm B: Aflibercept
55.0
49.7 – 60.2
Week 16
Group
Value
95% CI
Arm A: Faricimab
61.8
56.5 – 67.0
Arm B: Aflibercept
54.0
48.7 – 59.3
Week 20
Group
Value
95% CI
Arm A: Faricimab
60.2
54.8 – 65.6
Arm B: Aflibercept
55.5
50.0 – 60.9
Week 24
Group
Value
95% CI
Arm A: Faricimab
63.4
57.9 – 68.9
Arm B: Aflibercept
53.6
48.0 – 59.3
Week 28
Group
Value
95% CI
Arm A: Faricimab
60.8
55.3 – 66.3
Arm B: Aflibercept
61.4
55.8 – 67.0
Week 32
Group
Value
95% CI
Arm A: Faricimab
60.5
55.1 – 65.9
Arm B: Aflibercept
56.4
50.8 – 62.0
Percentage of Participants Gaining ≥0 Letters From the Baseline BCVA in the Study Eye Over TimeSecondary· 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 112
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 combine
Week 4
Group
Value
95% CI
Arm A: Faricimab
78.9
74.5 – 83.2
Arm B: Aflibercept
77.6
73.3 – 81.9
Week 8
Group
Value
95% CI
Arm A: Faricimab
80.7
76.4 – 84.9
Arm B: Aflibercept
78.3
73.9 – 82.7
Week 12
Group
Value
95% CI
Arm A: Faricimab
84.2
80.3 – 88.1
Arm B: Aflibercept
81.4
77.3 – 85.6
Week 16
Group
Value
95% CI
Arm A: Faricimab
84.8
80.9 – 88.7
Arm B: Aflibercept
78.8
74.6 – 83.1
Week 20
Group
Value
95% CI
Arm A: Faricimab
80.8
76.5 – 85.2
Arm B: Aflibercept
79.6
75.2 – 83.9
Week 24
Group
Value
95% CI
Arm A: Faricimab
81.9
77.5 – 86.3
Arm B: Aflibercept
79.6
75.1 – 84.1
Week 28
Group
Value
95% CI
Arm A: Faricimab
77.8
73.1 – 82.6
Arm B: Aflibercept
82.3
77.9 – 86.7
Week 32
Group
Value
95% CI
Arm A: Faricimab
78.7
74.2 – 83.1
Arm B: Aflibercept
76.3
71.5 – 81.0
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 48Secondary· Baseline, average of Weeks 40, 44, and 48
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 l
Avoiding a Loss of ≥15 Letters
Group
Value
95% CI
Arm A: Faricimab
95.4
93.0 – 97.7
Arm B: Aflibercept
94.1
91.5 – 96.7
Avoiding a Loss of ≥10 Letters
Group
Value
95% CI
Arm A: Faricimab
91.6
88.6 – 94.7
Arm B: Aflibercept
92.0
89.1 – 95.0
Avoiding a Loss of ≥5 Letters
Group
Value
95% CI
Arm A: Faricimab
88.0
84.3 – 91.6
Arm B: Aflibercept
86.8
83.0 – 90.5
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60Secondary· Baseline, average of Weeks 52, 56, and 60
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 l
Group
Value
95% CI
Arm A: Faricimab
93.9
91.3 – 96.5
Arm B: Aflibercept
94.1
91.4 – 96.8
Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Over TimeSecondary· 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 112
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., a
Week 4
Group
Value
95% CI
Arm A: Faricimab
97.6
95.9 – 99.2
Arm B: Aflibercept
99.0
98.0 – 100.0
Week 8
Group
Value
95% CI
Arm A: Faricimab
97.6
96.0 – 99.2
Arm B: Aflibercept
98.7
97.6 – 99.9
Week 12
Group
Value
95% CI
Arm A: Faricimab
98.2
96.7 – 99.6
Arm B: Aflibercept
97.5
95.8 – 99.1
Week 16
Group
Value
95% CI
Arm A: Faricimab
98.1
96.7 – 99.6
Arm B: Aflibercept
97.0
95.3 – 98.8
Week 20
Group
Value
95% CI
Arm A: Faricimab
97.4
95.7 – 99.1
Arm B: Aflibercept
94.9
92.5 – 97.3
Week 24
Group
Value
95% CI
Arm A: Faricimab
97.2
95.3 – 99.1
Arm B: Aflibercept
97.5
95.8 – 99.3
Week 28
Group
Value
95% CI
Arm A: Faricimab
95.9
93.8 – 98.1
Arm B: Aflibercept
96.7
94.6 – 98.8
Week 32
Group
Value
95% CI
Arm A: Faricimab
95.4
93.1 – 97.7
Arm B: Aflibercept
95.7
93.5 – 98.0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug through end of study (up to 112 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).
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: 23 July 2025
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/NCT03823287.