A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Choroidal Neovascularization

In brief

This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.

Key facts

Study ID

NCT02484690

Run by

Hoffmann-La Roche

People needed

273

Starts

2015-08-11

Expected to finish

2017-09-26

Last updated by the study team

2020-11-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT
• Active CNV

You may not qualify if…

• CNV due to causes other than AMD
• Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
• Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
• Major illness or surgery within 1 month prior to Screening
• Glycosylated hemoglobin (HbA1c) above 7.5%
• Uncontrolled blood pressure

Where it is running

• Retinal Consultants of Arizona — Phoenix, Arizona, 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, San Diego — Poway, California, United States
• Orange County Retina Med Group — Santa Ana, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• American Institute of Research — Whittier, California, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Colorado Retina Associates, PC — Golden, Colorado, United States
• New England Retina Associates — Hamden, Connecticut, United States
• Retina Health Center — Fort Myers, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Central Florida Retina — Orlando, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Midwest Eye Institute Northside — Indianapolis, Indiana, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Retina Group of Washington — Chevy Chase, Maryland, United States
• National Retina Institute — Towson, Maryland, United States
• Associated Retina Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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