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

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

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