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)
- Age-Related Macular Degeneration
- United States
Clinical Trial Results
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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
- 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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