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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neovascular (Wet) Age-Related Macular Degeneration
• Intervention / Treatment: Drug: AIV007; Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Detailed Description

This study will have 2 parts. In Part 1, participants will randomized to receive either AIV007 (6 or 8 mg) or standard of care in a masked fashion and followed for 6 months. The main questions to be answered are:

1. Does AIV007 have an acceptable safety profile?
2. Does AIV007 maintain or improve best corrected visual acuity?
3. Does AIV007 sustain or decrease central subfield thickness?
4. Does AIV007 provide a long duration of effect greater than or equal to 5 months? In Part 2, eligible participants will receive a second injection of AIV007 in an open-labeled design to assess safety and efficacy of repeat doses.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Darlene C. Deecher, phd; Phone Number: 2674544560; Email: darlene@aiviva.com
• Study Contact Backup: Name: Diane DS Tang-Liu, PHD; Phone Number: 7023371797; Email: diane@aiviva.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: AIV007	Drug: AIV007; 6 mg or 8 mg dose
Experimental: Group 2: AIV007	Drug: AIV007; 6 mg or 8 mg dose
Active Comparator: Group 3: Eylea	Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL); Eylea 2 mg, marketed product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected Visual Acuity	Mean change from baseline in best-corrected visual acuity using ETDRS Charts	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability	Proportion of participants that did not require supplemental medication	Month 5

Collaborators and Investigators

• Sponsor: AiViva BioPharma, Inc.
• Collaborators: ClinDatrix, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 23, 2027

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: tyrosine kinase inhibitor; anti-VEGF; Eylea; wet AMD; periocular
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; aflibercept
• Other Study ID Numbers: AIV007-E03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No