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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

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).

Key facts

Study ID

NCT03622580

Run by

Hoffmann-La Roche

People needed

940

Starts

2018-09-05

Expected to finish

2021-09-03

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

You may not qualify if…

• Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
• Uncontrolled blood pressure, defined as a systolic value greater than (>)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

Where it is running

• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Retina Associates Southwest PC — Tucson, Arizona, United States
• Retinal Diagnostic Center — Campbell, California, United States
• Eye Medical Center — Fresno, California, United States
• East Bay Retina Consultants — Oakland, California, United States
• Southern CA Desert Retina Cons — Palm Desert, California, United States
• California Eye Specialists Medical group Inc. — Pasadena, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Kaiser Permanente Riverside Medical Center — Riverside, California, United States
• University of California, Davis, Eye Center — Sacramento, California, United States
• W Coast Retina Med Group Inc — San Francisco, California, United States
• Orange County Retina Med Group — Santa Ana, California, United States
• Colorado Retina Associates, PC — Lakewood, Colorado, United States
• Rand Eye — Deerfield Beach, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Retina Associates of Florida, LLC — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Retina Consultants of Hawaii — ‘Aiea, Hawaii, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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