Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
- Sponsor
- AiViva BioPharma, Inc.
- Study ID
- NCT07557121
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Neovascular (Wet) Age-Related Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- AIV007 — DRUG6 mg or 8 mg dose
- EYLEA® (aflibercept) Injection 2 mg (0.05mL) — BIOLOGICALEylea 2 mg, marketed product
Study Details
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.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Jun 30, 2027
- Completion
- Aug 23, 2027
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Group 1: AIV007
- Experimental: Group 2: AIV007
- Active Comparator: Group 3: Eylea
Primary Outcome Measure
Best-corrected Visual Acuity [ Time Frame: Month 6 ]
Central Contacts
- Darlene C. Deecher, phd2674544560
- Diane DS Tang-Liu, PHD7023371797
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