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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
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Completed
This study runs in
Cities
- 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
Trial Identifier:
NCT02484690 BP29647
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT02484690, BP29647
Trial Identifier
Faricimab, Ranibizumab, Sham Procedure
Treatments
Choroidal Neovascularization
Condition
Official Title
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
All
Gender
≥50 Years
Age
No
Healthy Volunteers
Inclusion 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com