A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Key facts

Study ID

NCT04432831

Run by

Hoffmann-La Roche

People needed

1479

Starts

2020-08-05

Expected to finish

2023-10-11

Last updated by the study team

2026-02-09

Who can join

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

You may qualify if…

• Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation
• Ability to comply with the study protocol, in the investigator's judgment
• 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…

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab
• Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
• Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
• History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
• Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
• Retina Associates Southwest PC — Tucson, Arizona, United States
• California Retina Consultants. — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• Retinal Diagnostic Center — Campbell, California, United States
• The Retina Partners — Encino, California, United States
• Eye Medical Center — Fresno, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Southern California Permanente Medical Group — Los Angeles, California, United States
• Northern California Retina Vitreous Associates — Mountain View, 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
• Retinal Consultants Med Group — Sacramento, California, United States
• West Coast Retina Medical Group — San Francisco, California, United States
• Orange County Retina Med Group — Santa Ana, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• California Retina Consultants - Santa Maria — Santa Maria, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• University of Colorado; dept of ophthalmology — Aurora, Colorado, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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