Recruiting
Phase 2

AIV007

Sponsor:

AiViva BioPharma, Inc.

Code:

NCT07557121

Conditions

Neovascular (Wet) Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

AIV007

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

Study Details

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

Study ID

NCT07557121

Start date

Jul 1, 2026

Status verified date

Apr, 2026

Completion date

Aug 23, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1: AIV007

experimental: Group 2: AIV007

active comparator: Group 3: Eylea

Interventions

AIV007

6 mg or 8 mg dose

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

Eylea 2 mg, marketed product

Primary outcome measure

  • Best-corrected Visual Acuity [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Darlene C. Deecher, phd

2674544560darlene@aiviva.com

Diane DS Tang-Liu, PHD

7023371797diane@aiviva.com

Locations

Macula and Vitreous Center

Recruiting

Torrance, California, United States, 90503

Valley Retina Institute, P.A.

Recruiting

McAllen, Texas, United States, 78503

More Information

Sponsor

AiViva BioPharma, Inc.

Last update posted

Nov 4, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by AiViva BioPharma, Inc. on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.