Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorAiViva BioPharma, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- AIV007
- EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Treatment groups
35 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
AiViva BioPharma, Inc.
Lead sponsor
ClinDatrix, Inc.
Collaborator
Source ClinicalTrials.gov