Recruiting
Phase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Condition(s) studied
Neovascular (Wet) Age-Related Macular Degeneration
Investigational drug(s) / intervention(s)
AIV007: 6 mg or 8 mg dose
EYLEA® (aflibercept) Injection 2 mg (0.05mL): Eylea 2 mg, marketed product
Study 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.
Eligibility
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
Primary outcome measure(s)
- Best-corrected Visual Acuity — Month 6
Mean change from baseline in best-corrected visual acuity using ETDRS Charts
Trial sites (2)
| Facility | City | Region | Status |
| Macula and Vitreous Center |
Torrance |
California |
Recruiting |
| Valley Retina Institute, P.A. |
McAllen |
Texas |
Recruiting |
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