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

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

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.

Detailed description

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.

Interventions

• Drug AIV007
  6 mg or 8 mg dose
• Biological EYLEA® (aflibercept) Injection 2 mg (0.05mL)
  Eylea 2 mg, marketed product

Primary outcome measures

• Best-corrected Visual Acuity [Time frame: Month 6]

Secondary outcome measures (1)

• Durability [Time frame: Month 5]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07557121 · AIV007-E03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗