Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration

ConditionNeovascular (Wet) 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

AIV007
Drug
6 mg or 8 mg dose
EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Biological/Vaccine
Eylea 2 mg, marketed product

Treatment groups

35 Participants

are divided into 3 treatment groups

Group A: Group 1: AIV007Experimental treatment 1 intervention

Group B: Group 2: AIV007Experimental treatment 1 intervention

Group C: Group 3: EyleaActive comparator 1 intervention

Trial outcomes

Primary outcomes

Best-corrected Visual Acuity

Mean change from baseline in best-corrected visual acuity using ETDRS Charts

Time frame

Month 6

Secondary outcomes

Durability

Proportion of participants that did not require supplemental medication

Time frame

Month 5

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AiViva BioPharma, Inc.

Lead sponsor

ClinDatrix, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: