NCT03622593: RHINE

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Completed Phase 3 Results posted Last updated 11 July 2025

What this trial tests

Phase 3 trial testing Aflibercept in Diabetic Macular Edema in 951 participants. Completed in 31 May 2023.

Timeline

9 October 2018

Primary endpoint
19 October 2020

31 May 2023

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	951
Start date	9 October 2018
Primary completion	19 October 2020
Estimated completion	31 May 2023
Sites	188 locations across Hong Kong, Italy, Taiwan, Poland, South Korea, Denmark, Russia, Thailand

Drugs / interventions tested

• Aflibercept (AFLIBERCEPT) — full drug profile →
• Faricimab (FARICIMAB) — full drug profile →
• Sham Procedure — full drug profile →

Conditions studied

• Diabetic Macular Edema — all drugs for Diabetic Macular Edema →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Diabetic Macular Edema. 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 48, 52, and 56, ITT and Treatment-Naive Populations Primary · From Baseline through Week 56

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. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covari

ITT Population

Group	Value	95% CI
A: Faricimab 6 mg Q8W	11.8	10.6 – 13.0
B: Faricimab 6 mg PTI	10.8	9.6 – 11.9
C: Aflibercept 2 mg Q8W	10.3	9.1 – 11.4

Treatment-Naive Population

Group	Value	95% CI
A: Faricimab 6 mg Q8W	11.7	10.4 – 13.0
B: Faricimab 6 mg PTI	11.2	9.9 – 12.4
C: Aflibercept 2 mg Q8W	10.5	9.2 – 11.9

Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations Secondary · Baseline and Week 52

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the worl

ITT Population

Group	Value	95% CI
A: Faricimab 6 mg Q8W	44.2	37.1 – 51.4
B: Faricimab 6 mg PTI	43.7	36.8 – 50.7
C: Aflibercept 2 mg Q8W	46.8	39.8 – 53.8

Treatment-Naive Population

Group	Value	95% CI
A: Faricimab 6 mg Q8W	46.9	38.7 – 55.1
B: Faricimab 6 mg PTI	45.7	37.8 – 53.7
C: Aflibercept 2 mg Q8W	52.3	44.2 – 60.4

Change From Baseline in BCVA in the Study Eye Over Time, ITT Population Secondary · 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, and 100

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. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covari

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	6.1	5.4 – 6.8
B: Faricimab 6 mg PTI	6.6	5.8 – 7.3
C: Aflibercept 2 mg Q8W	6.4	5.7 – 7.1

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	7.8	7.0 – 8.5
B: Faricimab 6 mg PTI	8.1	7.4 – 8.9
C: Aflibercept 2 mg Q8W	7.5	6.8 – 8.3

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	8.7	7.8 – 9.5
B: Faricimab 6 mg PTI	9.1	8.2 – 9.9
C: Aflibercept 2 mg Q8W	8.5	7.7 – 9.4

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	9.9	9.0 – 10.7
B: Faricimab 6 mg PTI	9.8	9.0 – 10.7
C: Aflibercept 2 mg Q8W	8.8	7.9 – 9.6

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.1	9.2 – 10.9
B: Faricimab 6 mg PTI	9.5	8.6 – 10.4
C: Aflibercept 2 mg Q8W	8.8	8.0 – 9.7

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.6	9.7 – 11.5
B: Faricimab 6 mg PTI	9.9	9.0 – 10.8
C: Aflibercept 2 mg Q8W	9.3	8.4 – 10.2

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.7	9.7 – 11.6
B: Faricimab 6 mg PTI	10.5	9.6 – 11.4
C: Aflibercept 2 mg Q8W	9.6	8.7 – 10.5

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	11.3	10.3 – 12.3
B: Faricimab 6 mg PTI	10.2	9.2 – 11.1
C: Aflibercept 2 mg Q8W	9.4	8.5 – 10.4

Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population Secondary · 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, and 100

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 attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (\<64 vs. ≥64 letters), and region of enrollment. An unstructured covariance structure was used. Treatment p

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	6.0	5.2 – 6.9
B: Faricimab 6 mg PTI	6.7	5.8 – 7.5
C: Aflibercept 2 mg Q8W	6.3	5.4 – 7.1

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	7.5	6.6 – 8.4
B: Faricimab 6 mg PTI	8.2	7.3 – 9.1
C: Aflibercept 2 mg Q8W	7.3	6.4 – 8.2

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	8.7	7.8 – 9.6
B: Faricimab 6 mg PTI	9.2	8.3 – 10.1
C: Aflibercept 2 mg Q8W	8.5	7.6 – 9.5

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	9.7	8.8 – 10.7
B: Faricimab 6 mg PTI	10.0	9.1 – 10.9
C: Aflibercept 2 mg Q8W	8.7	7.8 – 9.6

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.0	9.1 – 11.0
B: Faricimab 6 mg PTI	9.8	8.8 – 10.7
C: Aflibercept 2 mg Q8W	9.0	8.1 – 10.0

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.6	9.6 – 11.6
B: Faricimab 6 mg PTI	10.2	9.2 – 11.2
C: Aflibercept 2 mg Q8W	9.4	8.4 – 10.4

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	10.8	9.8 – 11.8
B: Faricimab 6 mg PTI	10.8	9.8 – 11.8
C: Aflibercept 2 mg Q8W	9.9	8.9 – 10.9

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	11.2	10.1 – 12.3
B: Faricimab 6 mg PTI	10.3	9.2 – 11.4
C: Aflibercept 2 mg Q8W	9.9	8.8 – 11.0

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population Secondary · Baseline, average of Weeks 48, 52, and 56

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 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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by basel

Gaining ≥15 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	33.8	28.4 – 39.2
B: Faricimab 6 mg PTI	28.5	23.6 – 33.3
C: Aflibercept 2 mg Q8W	30.3	25.0 – 35.5

Gaining ≥10 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	59.3	53.6 – 64.9
B: Faricimab 6 mg PTI	53.0	47.5 – 58.5
C: Aflibercept 2 mg Q8W	53.9	48.3 – 59.5

Gaining ≥5 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	81.8	77.3 – 86.4
B: Faricimab 6 mg PTI	77.4	72.7 – 82.1
C: Aflibercept 2 mg Q8W	78.0	73.3 – 82.7

Gaining ≥0 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	92.1	89.0 – 95.3
B: Faricimab 6 mg PTI	91.1	87.8 – 94.3
C: Aflibercept 2 mg Q8W	91.4	88.2 – 94.6

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Trea

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	13.4	9.9 – 17.0
B: Faricimab 6 mg PTI	10.8	7.5 – 14.2
C: Aflibercept 2 mg Q8W	10.6	7.3 – 14.0

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	15.2	11.2 – 19.1
B: Faricimab 6 mg PTI	16.7	12.7 – 20.8
C: Aflibercept 2 mg Q8W	15.4	11.5 – 19.4

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	20.7	16.3 – 25.1
B: Faricimab 6 mg PTI	22.1	17.6 – 26.5
C: Aflibercept 2 mg Q8W	19.3	15.0 – 23.6

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	24.4	19.7 – 29.1
B: Faricimab 6 mg PTI	24.3	19.7 – 28.8
C: Aflibercept 2 mg Q8W	23.1	18.5 – 27.7

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	26.7	21.8 – 31.6
B: Faricimab 6 mg PTI	21.3	16.8 – 25.7
C: Aflibercept 2 mg Q8W	22.8	18.3 – 27.4

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	29.8	24.7 – 34.9
B: Faricimab 6 mg PTI	24.0	19.3 – 28.6
C: Aflibercept 2 mg Q8W	24.6	19.8 – 29.3

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	30.1	25.0 – 35.3
B: Faricimab 6 mg PTI	26.7	21.9 – 31.5
C: Aflibercept 2 mg Q8W	25.7	20.7 – 30.6

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	35.9	30.6 – 41.3
B: Faricimab 6 mg PTI	27.3	22.2 – 32.3
C: Aflibercept 2 mg Q8W	23.9	19.1 – 28.7

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Trea

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	29.1	24.2 – 34.0
B: Faricimab 6 mg PTI	26.9	22.1 – 31.8
C: Aflibercept 2 mg Q8W	28.7	23.8 – 33.6

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	39.7	34.4 – 45.1
B: Faricimab 6 mg PTI	41.4	36.0 – 46.9
C: Aflibercept 2 mg Q8W	34.8	29.6 – 40.0

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	44.8	39.3 – 50.2
B: Faricimab 6 mg PTI	46.9	41.4 – 52.4
C: Aflibercept 2 mg Q8W	43.2	37.7 – 48.8

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	52.5	46.9 – 58.0
B: Faricimab 6 mg PTI	51.3	45.9 – 56.7
C: Aflibercept 2 mg Q8W	41.8	36.3 – 47.3

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	54.0	48.6 – 59.5
B: Faricimab 6 mg PTI	50.0	44.5 – 55.6
C: Aflibercept 2 mg Q8W	45.5	40.0 – 51.0

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	57.0	51.5 – 62.5
B: Faricimab 6 mg PTI	52.8	47.4 – 58.3
C: Aflibercept 2 mg Q8W	48.4	42.9 – 53.9

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	58.3	52.7 – 63.9
B: Faricimab 6 mg PTI	51.3	45.8 – 56.8
C: Aflibercept 2 mg Q8W	51.7	46.1 – 57.3

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	60.1	54.4 – 65.8
B: Faricimab 6 mg PTI	50.9	45.2 – 56.6
C: Aflibercept 2 mg Q8W	52.5	46.8 – 58.1

Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Trea

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	57.8	52.3 – 63.2
B: Faricimab 6 mg PTI	61.8	56.4 – 67.2
C: Aflibercept 2 mg Q8W	59.2	53.7 – 64.6

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	67.0	61.9 – 72.2
B: Faricimab 6 mg PTI	68.8	63.7 – 73.9
C: Aflibercept 2 mg Q8W	66.0	60.7 – 71.2

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	70.9	65.9 – 76.0
B: Faricimab 6 mg PTI	74.3	69.4 – 79.2
C: Aflibercept 2 mg Q8W	72.5	67.4 – 77.5

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	75.4	70.6 – 80.2
B: Faricimab 6 mg PTI	74.6	69.9 – 79.4
C: Aflibercept 2 mg Q8W	69.6	64.4 – 74.8

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	76.0	71.2 – 80.8
B: Faricimab 6 mg PTI	79.5	75.1 – 84.0
C: Aflibercept 2 mg Q8W	71.4	66.3 – 76.6

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	78.3	73.7 – 83.0
B: Faricimab 6 mg PTI	76.3	71.6 – 80.9
C: Aflibercept 2 mg Q8W	72.2	67.2 – 77.2

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	76.8	72.0 – 81.7
B: Faricimab 6 mg PTI	79.4	74.8 – 83.9
C: Aflibercept 2 mg Q8W	77.2	72.4 – 81.9

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	80.0	75.4 – 84.6
B: Faricimab 6 mg PTI	78.3	73.6 – 83.0
C: Aflibercept 2 mg Q8W	75.9	70.9 – 80.8

Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Trea

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	85.1	81.2 – 89.0
B: Faricimab 6 mg PTI	89.2	85.8 – 92.7
C: Aflibercept 2 mg Q8W	89.3	85.9 – 92.8

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	90.2	86.9 – 93.5
B: Faricimab 6 mg PTI	91.3	88.2 – 94.4
C: Aflibercept 2 mg Q8W	90.3	87.0 – 93.6

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	90.8	87.6 – 94.0
B: Faricimab 6 mg PTI	92.7	89.8 – 95.6
C: Aflibercept 2 mg Q8W	90.4	87.1 – 93.7

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	92.4	89.4 – 95.3
B: Faricimab 6 mg PTI	91.1	88.0 – 94.3
C: Aflibercept 2 mg Q8W	90.9	87.7 – 94.1

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	92.2	89.1 – 95.3
B: Faricimab 6 mg PTI	91.7	88.6 – 94.8
C: Aflibercept 2 mg Q8W	93.9	91.2 – 96.6

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	91.5	88.3 – 94.7
B: Faricimab 6 mg PTI	91.5	88.5 – 94.6
C: Aflibercept 2 mg Q8W	91.5	88.4 – 94.7

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	92.2	89.1 – 95.4
B: Faricimab 6 mg PTI	94.3	91.7 – 96.8
C: Aflibercept 2 mg Q8W	94.0	91.4 – 96.7

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	91.4	88.2 – 94.7
B: Faricimab 6 mg PTI	90.9	87.6 – 94.2
C: Aflibercept 2 mg Q8W	92.8	89.8 – 95.8

Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population Secondary · Baseline, average of Weeks 48, 52, and 56

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 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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by basel

Gaining ≥15 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	32.9	26.7 – 39.0
B: Faricimab 6 mg PTI	29.4	23.9 – 34.9
C: Aflibercept 2 mg Q8W	32.7	26.5 – 38.8

Gaining ≥10 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	58.3	51.8 – 64.8
B: Faricimab 6 mg PTI	55.5	49.3 – 61.7
C: Aflibercept 2 mg Q8W	56.1	49.6 – 62.5

Gaining ≥5 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	81.8	76.5 – 87.0
B: Faricimab 6 mg PTI	79.6	74.5 – 84.7
C: Aflibercept 2 mg Q8W	80.6	75.4 – 85.8

Gaining ≥0 Letters

Group	Value	95% CI
A: Faricimab 6 mg Q8W	93.2	89.8 – 96.7
B: Faricimab 6 mg PTI	92.2	88.8 – 95.6
C: Aflibercept 2 mg Q8W	92.0	88.4 – 95.6

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 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 v

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	13.9	9.7 – 18.0
B: Faricimab 6 mg PTI	10.7	7.0 – 14.4
C: Aflibercept 2 mg Q8W	10.3	6.6 – 14.1

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	14.7	10.3 – 19.1
B: Faricimab 6 mg PTI	17.9	13.2 – 22.5
C: Aflibercept 2 mg Q8W	15.7	11.2 – 20.1

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	19.9	15.0 – 24.8
B: Faricimab 6 mg PTI	23.2	18.1 – 28.3
C: Aflibercept 2 mg Q8W	19.7	14.8 – 24.6

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	23.3	18.0 – 28.5
B: Faricimab 6 mg PTI	26.0	20.8 – 31.2
C: Aflibercept 2 mg Q8W	23.5	18.2 – 28.7

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	25.9	20.4 – 31.4
B: Faricimab 6 mg PTI	22.7	17.5 – 27.9
C: Aflibercept 2 mg Q8W	22.0	16.9 – 27.1

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	30.2	24.4 – 35.9
B: Faricimab 6 mg PTI	24.5	19.2 – 29.7
C: Aflibercept 2 mg Q8W	24.3	18.9 – 29.6

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	29.8	23.9 – 35.6
B: Faricimab 6 mg PTI	28.3	22.7 – 33.8
C: Aflibercept 2 mg Q8W	26.5	20.8 – 32.1

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	34.4	28.4 – 40.5
B: Faricimab 6 mg PTI	27.9	22.1 – 33.6
C: Aflibercept 2 mg Q8W	25.1	19.6 – 30.7

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population Secondary · 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, and 100

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 estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. \<64 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 v

Week 4

Group	Value	95% CI
A: Faricimab 6 mg Q8W	29.4	23.9 – 34.9
B: Faricimab 6 mg PTI	28.9	23.3 – 34.5
C: Aflibercept 2 mg Q8W	26.9	21.3 – 32.4

Week 8

Group	Value	95% CI
A: Faricimab 6 mg Q8W	38.2	32.3 – 44.1
B: Faricimab 6 mg PTI	42.2	36.1 – 48.3
C: Aflibercept 2 mg Q8W	33.1	27.2 – 38.9

Week 12

Group	Value	95% CI
A: Faricimab 6 mg Q8W	45.2	39.0 – 51.4
B: Faricimab 6 mg PTI	46.9	40.7 – 53.1
C: Aflibercept 2 mg Q8W	43.9	37.7 – 50.1

Week 16

Group	Value	95% CI
A: Faricimab 6 mg Q8W	52.3	46.2 – 58.5
B: Faricimab 6 mg PTI	51.4	45.4 – 57.4
C: Aflibercept 2 mg Q8W	41.7	35.5 – 48.0

Week 20

Group	Value	95% CI
A: Faricimab 6 mg Q8W	53.4	47.2 – 59.6
B: Faricimab 6 mg PTI	51.1	44.9 – 57.4
C: Aflibercept 2 mg Q8W	45.5	39.2 – 51.8

Week 24

Group	Value	95% CI
A: Faricimab 6 mg Q8W	57.8	51.6 – 64.1
B: Faricimab 6 mg PTI	53.1	46.9 – 59.2
C: Aflibercept 2 mg Q8W	49.3	43.1 – 55.5

Week 28

Group	Value	95% CI
A: Faricimab 6 mg Q8W	59.7	53.4 – 66.1
B: Faricimab 6 mg PTI	53.1	46.9 – 59.4
C: Aflibercept 2 mg Q8W	55.3	49.0 – 61.6

Week 32

Group	Value	95% CI
A: Faricimab 6 mg Q8W	61.2	54.7 – 67.6
B: Faricimab 6 mg PTI	50.6	44.2 – 57.1
C: Aflibercept 2 mg Q8W	55.7	49.2 – 62.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline until Week 100. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

A: Faricimab 6 mg Q8W

Serious: 97/317 (31%)

Deaths: 12/317

B: Faricimab 6 mg PTI

Serious: 82/319 (26%)

Deaths: 9/319

C: Aflibercept 2 mg Q8W

Serious: 100/314 (32%)

Deaths: 10/314

Serious adverse events (212 terms)

Reaction	System	A: Faricimab 6 mg Q8W	B: Faricimab 6 mg PTI	C: Aflibercept 2 mg Q8W
Cardiac failure congestive	Cardiac disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—
Cataract	Eye disorders	—	—	—
Diabetic retinal oedema	Eye disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
COVID-19	Infections and infestations	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Sepsis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Cardiac failure	Cardiac disorders	—	—	—
Vitreous haemorrhage	Eye disorders	—	—	—
Diabetic foot infection	Infections and infestations	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—
Chronic kidney disease	Renal and urinary disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Diabetic retinopathy	Eye disorders	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
End stage renal disease	Renal and urinary disorders	—	—	—
Renal failure	Renal and urinary disorders	—	—	—
Ischaemic stroke	Nervous system disorders	—	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	A: Faricimab 6 mg Q8W	B: Faricimab 6 mg PTI	C: Aflibercept 2 mg Q8W
Cataract	Eye disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—
Diabetic retinal oedema	Eye disorders	—	—	—
Vitreous detachment	Eye disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Hypertension	Vascular disorders	—	—	—
Dry eye	Eye disorders	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Vitreous floaters	Eye disorders	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—

Most-reported serious reactions: Cardiac failure congestive, Cellulitis, Cataract, Diabetic retinal oedema, Pneumonia, COVID-19, Myocardial infarction, Sepsis.

Data from ClinicalTrials.gov NCT03622593 adverse events section.

Sponsor's own description

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.