Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macul… (NCT07557121) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
35 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range50 Years – 85 Years
SexALL
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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 infe…