Phase 3
Completed N=951
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema
Source: ClinicalTrials.gov NCT03622593 ↗Enrolled (actual)
951
Serious AEs
29.4%
Results posted
Mar 2022
Primary outcomePrimary: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations — 11.8; 10.8; 10.3; 11.7 ETDRS Letters — p=0.1718
◆ Published Evidence
Highly cited
135citations · ~68 / year
Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials.
Summary
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).
Linked Publications (5)
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Faricimab Treat-and-Extend for Diabetic Macular Edema: Two-Year Results from the Randomized Phase 3 YOSEMITE and RHINE Trials.
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IMPACT OF FARICIMAB VERSUS AFLIBERCEPT ON EPIRETINAL MEMBRANE FORMATION OVER 2 YEARS IN PATIENTS WITH DIABETIC MACULAR EDEMA IN THE PHASE 3 YOSEMITE AND RHINE TRIALS.
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Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials.
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Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results from the RHONE-X Extension Trial.
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Efficacy, Durability, and Safety of Faricimab for Diabetic Macular Edema: 1-Year Results from the China RHINE Subpopulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
11.8; 10.8; 10.3; 11.7; 11.2; 10.5 | 0.1718 |
| SECONDARY 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 |
44.2; 43.7; 46.8; 46.9; 45.7; 52.3 | 0.3009 |
| SECONDARY Change From Baseline in BCVA in the Study Eye Over Time, ITT Population |
6.1; 6.6; 6.4; 7.8; 8.1; 7.5 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population |
6.0; 6.7; 6.3; 7.5; 8.2; 7.3 | — |
| SECONDARY 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 |
33.8; 28.5; 30.3; 59.3; 53.0; 53.9 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
13.4; 10.8; 10.6; 15.2; 16.7; 15.4 | — |
| SECONDARY Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
29.1; 26.9; 28.7; 39.7; 41.4; 34.8 | — |
| SECONDARY Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
57.8; 61.8; 59.2; 67.0; 68.8; 66.0 | — |
| SECONDARY Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
85.1; 89.2; 89.3; 90.2; 91.3; 90.3 | — |
| SECONDARY 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 |
32.9; 29.4; 32.7; 58.3; 55.5; 56.1 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
13.9; 10.7; 10.3; 14.7; 17.9; 15.7 | — |
| SECONDARY Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
29.4; 28.9; 26.9; 38.2; 42.2; 33.1 | — |
| SECONDARY Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
57.9; 62.2; 58.3; 65.6; 68.3; 65.3 | — |
| SECONDARY Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
84.9; 88.5; 88.8; 89.3; 90.6; 90.1 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population |
98.9; 98.7; 98.6; 98.1; 98.0; 98.2 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
99.4; 100.0; 100.0; 99.7; 100.0; 99.7 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
99.4; 99.3; 99.4; 99.0; 99.4; 99.0 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
95.1; 97.4; 97.7; 96.7; 97.1; 97.1 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population |
98.5; 98.7; 98.6; 98.1; 97.8; 98.1 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
99.6; 100.0; 100.0; 100.0; 100.0; 99.6 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
99.6; 99.2; 99.2; 99.2; 99.2; 98.8 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
95.5; 97.1; 97.5; 96.3; 97.1; 96.3 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
38.3; 32.4; 33.5; 38.1; 34.4; 35.5 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population |
14.7; 13.0; 13.2; 17.3; 20.4; 18.1 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population |
15.1; 13.5; 12.8; 17.0; 22.2; 17.7 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
73.2; 71.6; 68.5; 73.6; 74.2; 72.1 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population |
56.7; 57.8; 54.4; 61.3; 65.7; 59.4 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population |
57.5; 59.9; 56.0; 62.3; 67.0; 59.9 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
0.8; 0.0; 0.7; 1.0; 0.0; 0.5 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population |
1.6; 1.7; 0.3; 1.3; 0.6; 0.3 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population |
2.0; 1.7; 0.4; 1.6; 0.8; 0.4 | — |
| SECONDARY Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population |
34.5; 38.0; 34.0; 43.4; 43.9; 46.2 | — |
| SECONDARY Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population |
37.2; 39.5; 37.3; 46.0; 46.2; 51.3 | — |
| SECONDARY Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population |
12.8; 17.0; 13.4; 16.3; 19.2; 19.2 | — |
| SECONDARY Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population |
14.2; 16.6; 14.4; 18.9; 19.0; 21.6 | — |
| SECONDARY Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population |
3.6; 8.3; 3.4; 4.1; 7.3; 4.9 | — |
| SECONDARY Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population |
3.6; 6.5; 3.3; 5.1; 6.3; 4.6 | — |
| SECONDARY Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations |
0.8; 0.9; 0.4; 0.6; 1.2; 0.0 | — |
| SECONDARY Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population |
13.3; 15.6; 20.1; 51.0 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population |
11.8; 13.9; 20.0; 54.3 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population |
10.1; 11.8; 13.6; 64.5 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population |
9.3; 9.7; 12.8; 68.3 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations |
64.3; 66.9 | — |
| SECONDARY Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations |
63.1; 65.6 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
-195.8; -187.6; -170.1; -195.0; -189.4; -175.1 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population |
-106.1; -113.9; -107.3; -132.0; -139.6; -129.6 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population |
-106.3; -112.9; -106.3; -131.8; -140.6; -130.4 | — |
| SECONDARY Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
85.5; 81.5; 73.2; 86.0; 83.2; 77.0 | — |
| SECONDARY Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population |
38.2; 43.5; 38.1; 53.3; 57.3; 47.9 | — |
| SECONDARY Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population |
12.3; 18.5; 15.0; 26.2; 25.9; 22.5 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population |
19.6; 19.8; 13.3; 40.9; 32.3; 22.5 | — |
| SECONDARY Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population |
99.0; 96.7; 95.6; 97.2; 95.8; 95.3 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population |
19.6; 19.1; 13.3; 40.5; 31.2; 22.5 | — |
| SECONDARY Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population |
5.7; 6.5; 7.0; 6.8; 6.6; 7.6 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event |
89.3; 85.3; 87.3; 30.6; 25.7; 31.8 | — |
| SECONDARY Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye |
52.4; 51.7; 44.6; 4.4; 6.3; 4.1 | — |
| SECONDARY Percentage of Participants With at Least One Non-Ocular Adverse Event |
69.4; 68.3; 73.6; 24.0; 20.1; 28.3 | — |
| SECONDARY Plasma Concentration of Faricimab Over Time |
0.0001; 0.0000; 0.0192; 0.0196; 0.0030; 0.0115 | — |
| SECONDARY Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study |
7.0; 8.2; 7.0; 8.2; 0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of )180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
- Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
- Prior administration of IVT faricimab in either eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03622593) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.