A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age‑Related Macular Degeneration (AMD) (AVENUE)
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
- Eye Disorder
- Age-Related Macular Degeneration
- Choroidal neovascularization
Completed
- Abilene
- Albuquerque
- Asheville
- Augusta
- Austin
- Bakersfield
- Beverly Hills
- Carmel
- Charlotte
- Charlottesville
- Chattanooga
- Chevy Chase
- Colorado Springs
- Columbus
- Edina
- Eugene
- Fort Myers
- Germantown
- Great Neck
- Hamden
- Houston
- Lakewood
- Los Angeles
- Lynbrook
- Marietta
- Medford
- Melbourne
- Murray
- Nashville
- Orlando
- Paducah
- Palm Beach Gardens
- Philadelphia
- Phoenix
- Portland
- Poway
- Rochester
- Santa Ana
- Slingerlands
- Spokane
- St. Petersburg
- Tallahassee
- Toms River
- Walnut Creek
- west-columbia
- Whittier
- Willow Park
- Worcester
NCT02484690 BP29647
Study Summary
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.
A Multiple-Center, Multiple-Dose and Regimen, Randomized, Active Comparator Controlled, Double-Masked, Parallel Group, 36 Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Eligibility Criteria
- 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
- 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
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