A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
Completed · Phase 3 · Has a placebo group
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.
Key facts
- Study ID
- NCT04777201
- Run by
- Hoffmann-La Roche
- People needed
- 1036
- Starts
- 2021-04-19
- Expected to finish
- 2024-09-03
- Last updated by the study team
- 2025-10-24
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States
- Associated Retina Consultants — Phoenix, Arizona, United States
- Retina Associates Southwest PC — Tucson, Arizona, United States
- Retinal Diagnostic Center — Campbell, California, United States
- The Retina Partners — Encino, California, United States
- South Coast Retina Center — Los Angeles, California, United States
- Northern California Retina Vitreous Associates — Mountain View, 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
- University of California, Davis, Eye Center — Sacramento, California, United States
- Retinal Consultants Med Group — Sacramento, California, United States
- Orange County Retina Med Group — Santa Ana, California, United States
- California Retina Consultants — Santa Barbara, California, United States
- Retina Consultants of Southern — Colorado Springs, Colorado, United States
- Colorado Retina Associates, PC — Lakewood, Colorado, United States
- Retina Group of New England — Waterford, Connecticut, United States
- Rand Eye — Deerfield Beach, Florida, United States
- Retina Group of Florida — Fort Lauderdale, Florida, United States
- Florida Eye Associates — Melbourne, Florida, United States
- Retina Care Specialists — Palm Beach Gardens, Florida, United States
- Retina Specialty Institute — Pensacola, Florida, United States
- Fort Lauderdale Eye Institute — Plantation, Florida, United States
- Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States
Full record on ClinicalTrials.gov
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