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

NCT07557121 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: AIV007-E03
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neovascular (Wet) Age-Related Macular Degeneration

Keywords

wet AMD; anti-VEGF; periocular; Eylea; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Best-corrected Visual Acuity

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

  Month 6

Secondary Outcomes (1)

• Durability

  Month 5

Study Arms (3)

Group 1: AIV007

EXPERIMENTAL

Drug: AIV007

Group 2: AIV007

EXPERIMENTAL

Drug: AIV007

Group 3: Eylea

ACTIVE COMPARATOR

Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL)

Interventions

AIV007 DRUG

6 mg or 8 mg dose

Group 1: AIV007; Group 2: AIV007

EYLEA® (aflibercept) Injection 2 mg (0.05mL) BIOLOGICAL

Eylea 2 mg, marketed product

Group 3: Eylea

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AiViva BioPharma, Inc.: lead
• ClinDatrix, Inc.: collaborator

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept; Injections

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Darlene C. Deecher, phd

CONTACT

2674544560; darlene@aiviva.com

Diane DS Tang-Liu, PHD

CONTACT

7023371797; diane@aiviva.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Central Reading Center, Sub-PI, BCVA technicans
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 Single AIV007 Dose Multicenter, Randomized, Active-controlled Trial Part 2 Open-Label Repeat AIV007 Dose

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 23, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04