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

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

NCT03622593

Run by

Hoffmann-La Roche

People needed

951

Starts

2018-10-09

Expected to finish

2023-05-31

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 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

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Northwest Arkansas Retina Associates — Springdale, Arkansas, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• California Retina Consultants — Santa Maria, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• University of Colorado — Aurora, Colorado, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University Retina and Macula Associates, PC — Oak Forest, Illinois, United States
• Prairie Retina Center — Springfield, Illinois, United States
• Retina Specialists — Baltimore, Maryland, United States
• Associated Retina Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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