AiViva BioPharma, Inc.
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.
This study will have 2 parts. In Part 1, participants will randomized to receive either AIV007 (6 or 8 mg) or standard of care in a masked fashion and followed for 6 months. The main questions to be answered are: 1. Does AIV007 have an acceptable safety profile? 2. Does AIV007 maintain or improve best corrected visual acuity? 3. Does AIV007 sustain or decrease central subfield thickness? 4. Does AIV007 provide a long duration of effect greater than or equal to 5 months? In Part 2, eligible participants will receive a second injection of AIV007 in an open-labeled design to assess safety and ef…
Inclusion Criteria: * Previously treated neovascular (wet) age-related macular degeneration (nAMD) * Responsive to prior intravitreal anti-VEGF therapy * Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent) * Active choroidal neovascularization lesion in the study eye secondary to nAMD. * Central subfield thickness in the study eye of less than or equal to 370 microns. * Compliance to all study protocol requirements Exclusion Criteria: * Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy * History of uncon…
6 mg or 8 mg dose
Eylea 2 mg, marketed product
Arctuva estimate
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