Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02484690

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Choroidal Neovascularization

Interventions: Faricimab, Ranibizumab, Sham Procedure

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (52)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Bakersfield, California, United States
  • Beverly Hills, California, United States
  • Encino, California, United States
  • Poway, California, United States
  • Santa Ana, California, United States
  • Walnut Creek, California, United States
  • Whittier, California, United States
  • Colorado Springs, Colorado, United States
  • Golden, Colorado, United States
  • Hamden, Connecticut, United States
  • Fort Myers, Florida, United States
  • Fort Myers, Florida, United States
  • Melbourne, Florida, United States
  • Orlando, Florida, United States
  • Palm Beach Gardens, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Augusta, Georgia, United States
  • Marietta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Paducah, Kentucky, United States
  • Chevy Chase, Maryland, United States
  • Towson, Maryland, United States
  • Worcester, Massachusetts, United States
  • Edina, Minnesota, United States
  • Toms River, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • Great Neck, New York, United States
  • + 22 more on CT.gov