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

Roche

Status and phase: Completed; Phase 2

Conditions: Choroidal Neovascularization

Treatments: Drug: Sham Procedure; Drug: Ranibizumab; Drug: Faricimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02484690

BP29647

Details and patient eligibility

About

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.

Enrollment: 273 patients

Sex: All

Ages: 50+ years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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273 participants in 5 patient groups

Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)

Active Comparator group

Description:

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.

Treatment:

Drug: Ranibizumab

Arm B: Faricimab, 1.5 mg Q4W

Experimental group

Description:

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.

Treatment:

Drug: Faricimab

Arm C: Faricimab, 6 mg Q4W

Experimental group

Description:

Participants will receive faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit will take place at Week 36.

Treatment:

Drug: Faricimab

Arm D: Faricimab, 6 mg Every 4-8 weeks

Experimental group

Description:

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.

Treatment:

Drug: Faricimab

Drug: Sham Procedure

Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W

Experimental group

Description:

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.

Treatment:

Drug: Faricimab

Drug: Ranibizumab