AIV007 Periocular Shot for Wet AMD
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
Run by AiViva BioPharma, Inc. · NCT07557121 · Data updated 2026-11-12
This trial tests whether a periocular injection of AIV007 can improve vision and safety in people with wet age-related macular degeneration, compared with the standard Eylea injections.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | AiViva BioPharma, Inc. Industry-sponsored |
| Locations | 2 sites (Torrance, California and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | August 23, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07557121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with previously treated, responsive wet AMD, an ETDRS score above 35 in the study eye, active choroidal neovascularization, and controlled central subfield thickness.
✕Probably not a fit
Patients with prior eye conditions or recent procedures that exclude eligibility, or those who do not respond to anti-VEGF therapy, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 2 interventional study evaluating AIV007 given by periocular injection versus intravitreal Eylea in the study eye of adults with neovascular AMD. Part 1 randomizes participants to AIV007 (6 or 8 mg) or standard-of-care and follows them for 6 months to assess safety, visual acuity, and retinal thickness, with a potential duration of effect of 5 months or more. Part 2 opens as an extension where eligible participants receive a second AIV007 injection to evaluate safety and efficacy of repeat dosing. Outcomes include safety, best-corrected visual acuity, central subfield thickness, and duration of effect. The trial is sponsored by AiViva Biopharma with ClinDatrix as a collaborator and is conducted at two U.S. centers.
Why it matters
Potential benefit: If successful, AIV007 could offer a lasting treatment option with similar or improved vision benefits and a potentially different dosing schedule compared to current therapies.
How similar studies have gone: Earlier studies of periocular therapies for AMD have shown mixed results; this study tests a novel agent with a designed long duration of effect.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Macula and Vitreous Center
Torrance, California, United States Recruiting -
Valley Retina Institute, P.A.
McAllen, Texas, United States Recruiting
Study contacts
- Study coordinator: Darlene C. Deecher, phd
- Email: darlene@aiviva.com
- Phone: 2674544560
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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EYC-0305 in Neovascular (Wet) AMD: First-in-Patients Safety and Tolerability Study
This study tests whether EYC-0305 given as an eye injection every 24 weeks is safe and tolerable in people 50 and older with wet AMD.
-
Long-term follow-up for patients with wet age-related macular degeneration receiving SKG0106
This study is testing how well and safely the treatment SKG0106 works for people with wet age-related macular degeneration over a long period after their last injection.
-
Treatment for wet age-related macular degeneration using 4D-150
This study is testing a new gene therapy called 4D-150 to see if it can improve vision in adults with wet age-related macular degeneration who are already receiving other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.