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

• Status: Completed
• Trial end date: 2017-09-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ranibizumab

Criteria

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