AIV007 Injected Around the Eye for Wet Age-Related Macular Degeneration, Compared With Eylea
Tests AIV007 injected near the eye in adults with wet macular degeneration.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Key facts
- Where
- McAllen and Torrance, United StatesSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 85 years old?
Source: NCT07557121, who can take part
Where in United States
- Valley Retina Institute P.A.McAllen, United StatesTaking people
- Macula and Vitreous CenterTorrance, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AiViva BioPharma, Inc.
- Trial code
- NCT07557121
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy; 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; 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; History of uncontrolled intraocular pressure; Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye; Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye; A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye; Intraretinal fluid (IRF) in the proposed study eye of less than 30 µm confirmed by the CRC following the screening visit.