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

Conditions

• Choroidal Neovascularization

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Faricimab — DRUG
  Faricimab will be administered as per the regimen specified in the individual arm.
• Ranibizumab — DRUG
  Ranibizumab will be administered as per the regimen specified in the individual arm.
• Sham Procedure — DRUG
  The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.

Study Details

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.

Key Dates

First listed

Jun 30, 2015

Start date

Aug 11, 2015

Status verified

Oct 2020

Primary completion

Sep 26, 2017

Completion

Sep 26, 2017

Study Design

Enrollment

273 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
  Participants will receive ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36.
• Experimental: Arm B: Faricimab, 1.5 mg Q4W
  Participants will receive faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36.
• Experimental: Arm C: Faricimab, 6 mg Q4W
  Participants will receive faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit will take place at Week 36.
• Experimental: Arm D: Faricimab, 6 mg Every 4-8 weeks
  Participants will receive faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit will take place at Week 36.
• Experimental: Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
  Participants will receive ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit will take place at Week 36.

Primary Outcome Measure

Mean Change From Baseline in BCVA Letter Score at Week 36, in Treatment-Naive Participants [ Time Frame: Baseline, Week 36 ]

Locations (52)

Find similar trials in Phoenix, AZ

Related Studies

• A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
  PHASE2/PHASE3 · Recruiting · EyeBiotech Ltd. · Scottsdale, Arizona
• A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-003)
  PHASE2/PHASE3 · Recruiting · EyeBiotech Ltd. · Gilbert, Arizona