Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration

Phase 2Not Yet RecruitingNCT07557121

AiViva BioPharma, Inc.35 enrolled

Overview

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 efficacy of repeat doses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neovascular (Wet) Age-Related Macular Degeneration

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 uncontrolled intraocular pressure * Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye * History of vitreoretinal surgery, corneal transplant, glaucoma surgery in the study eye or cataract surgery within 3 months before screening visit * History of vitreous hemorrhage within 3 months prior to screening visit in the study eye * A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye * Anterior chamber intraocular lens, aphakia, or violation of the posterior capsule in the study eye; prior Nd:YAG laser posterior capsulotomy in association with posterior intraocular lens implantation is allowed provided it occurred at least 30 days before the screening visit * Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye * Intraretinal fluid (IRF) in the proposed study eye of less than 30 µm confirmed by the CRC following the screening visit

Outcomes

Primary Outcomes

Best-corrected Visual Acuity

Mean change from baseline in best-corrected visual acuity using ETDRS Charts

Time frame: Month 6

Secondary Outcomes

Durability

Proportion of participants that did not require supplemental medication

Time frame: Month 5