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Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Sponsor: AiViva BioPharma, Inc.
Summary
The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile. Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.
Official title: A Phase 2, Multicenter, Randomized, Active-controlled Trial of the Safety and Efficacy of AIV007 by Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2026-07-01
Completion Date
2027-08-23
Last Updated
2026-04-29
Healthy Volunteers
No
Interventions
AIV007
6 mg or 8 mg dose
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Eylea 2 mg, marketed product