NCT07557121Not yet recruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
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
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 23 Apr 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- AiViva BioPharma, Inc.
- Diseases
- Macular degeneration
- NCT number
- NCT07557121
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 1 Jul 2026 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of uncontrolled intraocular pressure
- Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye
Other
- 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
Who the study is looking for
- 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
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.