Phase 3
Completed N=940
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
Source: ClinicalTrials.gov NCT03622580 ↗Enrolled (actual)
940
Serious AEs
34.3%
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 — 10.7; 11.6; 10.9; 10.6 ETDRS Letters — p=0.4699
◆ 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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Efficacy of Faricimab versus Aflibercept in Diabetic Macular Edema in the 20/50 or Worse Vision Subgroup in Phase III 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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Four-Year Outcomes of Faricimab in Diabetic Macular Edema: Results from the RHONE-X Extension Trial.
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Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial.
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 |
10.7; 11.6; 10.9; 10.6; 11.4; 11.3 | 0.4699 |
| SECONDARY Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations |
46.0; 42.5; 35.8; 49.7; 47.6; 42.5 | 0.1761 |
| SECONDARY Change From Baseline in BCVA in the Study Eye Over Time, ITT Population |
5.5; 6.7; 6.5; 7.2; 8.2; 8.1 | — |
| SECONDARY Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population |
5.8; 6.8; 6.9; 7.2; 8.3; 8.7 | — |
| 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 |
29.2; 35.5; 31.8; 57.2; 58.3; 57.6 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
7.7; 13.0; 11.4; 13.4; 18.8; 16.7 | — |
| SECONDARY Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
23.9; 31.1; 27.1; 30.8; 37.1; 41.0 | — |
| SECONDARY Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
53.6; 62.6; 61.1; 64.7; 71.1; 67.6 | — |
| SECONDARY Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
86.1; 90.8; 88.9; 89.7; 91.9; 91.1 | — |
| 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 |
28.6; 35.5; 33.8; 57.5; 59.6; 57.5 | — |
| SECONDARY Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
8.9; 14.9; 12.7; 14.3; 19.2; 17.8 | — |
| SECONDARY Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
25.2; 32.0; 29.2; 31.1; 37.2; 43.9 | — |
| SECONDARY Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
53.8; 63.1; 62.8; 63.4; 70.5; 70.4 | — |
| SECONDARY Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
86.3; 90.9; 90.2; 91.4; 93.3; 93.1 | — |
| 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 |
98.1; 98.6; 98.9; 96.3; 98.2; 98.1 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
100.0; 100.0; 100.0; 99.7; 100.0; 99.3 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
98.7; 100.0; 99.4; 98.4; 100.0; 99.0 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population |
97.7; 97.4; 96.4; 96.4; 98.7; 97.3 | — |
| 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 |
97.9; 98.1; 99.0; 96.5; 97.7; 98.6 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
100.0; 100.0; 100.0; 99.6; 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; 100.0; 99.2; 98.3; 100.0; 99.6 | — |
| SECONDARY Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population |
98.7; 97.5; 97.0; 96.5; 99.2; 98.3 | — |
| 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 |
32.1; 39.1; 37.0; 31.5; 39.2; 40.2 | — |
| 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 |
8.7; 14.6; 13.3; 15.3; 20.1; 19.9 | — |
| 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 |
9.8; 17.0; 15.2; 16.0; 20.9; 22.2 | — |
| 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 |
71.6; 77.1; 74.8; 72.7; 75.7; 77.4 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population |
53.3; 60.0; 57.5; 60.0; 65.5; 66.1 | — |
| 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 |
55.7; 60.4; 60.4; 62.0; 66.5; 69.6 | — |
| 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 |
2.3; 1.9; 1.7; 2.6; 1.9; 1.8 | — |
| SECONDARY Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population |
1.9; 2.6; 1.6; 2.0; 3.0; 2.0 | — |
| 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 |
1.7; 2.9; 1.3; 2.2; 3.3; 2.1 | — |
| 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 |
36.7; 35.0; 28.9; 46.2; 42.3; 35.4 | — |
| 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, Treatment-Naive Population |
39.3; 39.5; 33.3; 49.5; 47.4; 42.3 | — |
| 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 |
12.7; 12.8; 10.3; 17.0; 15.3; 14.2 | — |
| 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 |
14.4; 15.1; 10.4; 19.5; 17.4; 16.4 | — |
| 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; 3.5; 3.9; 5.8; 4.9; 4.5 | — |
| 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 |
3.9; 3.5; 3.6; 6.2; 5.1; 4.2 | — |
| SECONDARY Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations |
0.9; 0.9; 0.5; 0.0; 1.2; 0.6 | — |
| 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 |
0.4; 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 |
10.8; 15.4; 21.0; 52.8 | — |
| 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 |
9.0; 14.4; 22.1; 54.5 | — |
| 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, ITT Population |
7.0; 14.8; 18.1; 60.0 | — |
| 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 96, Treatment-Naive Population |
7.2; 11.1; 16.8; 64.9 | — |
| 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 |
67.8; 71.6 | — |
| 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 |
60.4; 64.4 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations |
-206.6; -196.5; -170.3; -204.6; -197.5; -173.6 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population |
-118.4; -124.9; -111.0; -145.9; -149.6; -130.9 | — |
| SECONDARY Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population |
-116.1; -121.5; -110.1; -142.9; -147.4; -131.5 | — |
| 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 |
81.3; 78.0; 65.4; 83.5; 80.4; 68.3 | — |
| SECONDARY Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population |
36.1; 41.3; 35.0; 48.4; 52.7; 42.6 | — |
| SECONDARY Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population |
15.4; 16.0; 12.6; 24.2; 24.6; 16.2 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population |
16.3; 21.9; 13.4; 45.6; 33.2; 21.9 | — |
| SECONDARY Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population |
95.3; 94.5; 95.9; 97.0; 95.5; 96.2 | — |
| SECONDARY Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population |
15.9; 21.9; 13.1; 45.2; 32.4; 21.9 | — |
| SECONDARY Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population |
6.0; 6.9; 6.0; 7.3; 7.9; 7.5 | — |
| SECONDARY Percentage of Participants With at Least One Adverse Event |
92.7; 91.4; 89.1; 35.5; 37.4; 29.9 | — |
| SECONDARY Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye |
47.0; 46.6; 46.3; 3.8; 4.5; 2.3 | — |
| SECONDARY Percentage of Participants With at Least One Non-Ocular Adverse Event |
76.7; 80.2; 77.8; 31.6; 31.0; 27.0 | — |
| SECONDARY Plasma Concentration of Faricimab Over Time |
0.0000; 0.0000; 0.0211; 0.0181; 0.0033; 0.0089 | — |
| SECONDARY Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study |
12.6; 10.6; 12.6; 10.3; 0.0; 0.3 | — |
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 the past 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 (NCT03622580) 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.