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

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:

• Does AIV007 have an acceptable safety profile?
• Does AIV007 maintain or improve best corrected visual acuity?
• Does AIV007 sustain or decrease central subfield thickness?
• 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.

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