Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54-VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

February 10, 2026 updated by: Avirmax Biopharma Inc

A Phase 1/2a, Open-Label, Multiple-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravitreal (IVT) Injection of ABI-110 (AAV2.N54- VEGF Trap) in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (wAMD), Including Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

This will be a clinical study to assess initial safety and tolerability of IVT ABI-110 in patients diagnosed with wet macular degeneration (wAMD), including symptomatic macular PCV.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/2a, open-label, multiple-cohort, dose-escalation study to evaluate the safety, tolerability, and preliminary efficacy of IVT ABI-110 (AAV2.N54-VEGF-Trap) injection in subjects with wAMD), including symptomatic macular PCV.

This trial will include a screening period, confirmation of response to EYLEA (aflibercept), single administration of ABI-110, and follow-up period of 104 weeks after IVT ABI-110 injection.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Texas
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of Texas - San Antonio
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • General:

    1. Must be willing and able to provide written, signed informed consent.

    2. Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent

      Study eye:

    3. Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
    4. The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
    5. BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters)
    6. History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
    7. Response to anti-VEGF at trial entry

Key Exclusion Criteria:

  • Study or Fellow Eye:

    1. Prior gene therapy, either eye
    2. Any active ocular/intraocular infection or inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis) or history of idiopathic or autoimmune-associated uveitis, either eye
    3. History of retinal disease other than wAMD or PCV, study eye
    4. Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
    5. History of (or active) retinal detachment, study eye
    6. Uncontrolled glaucoma (defined as IOP > 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
    7. History of intravitreal therapy, (other than anti-VEGF therapy) such as intravitreal steroid injection or investigational product, in the 6 months prior to screening, study eye
    8. Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
    9. History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose level 1
Low Dose
Drug: ABI-110 Low Dose
Low dose. lower than the safety factor of 10 as recommended by the FDA
Experimental: Dose level 2
Medium Dose
Drug: ABI-110 Medium Dose
Medium dose
Experimental: Dose level 3
High Dose
Drug: ABI-110 High Dose
High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 52 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary Efficacy
Time Frame: 52 weeks
Change from baseline to Week 52 after ABI-110 treatment in BCVA as assessed by ETDRS chart at a starting distance of 4M
52 weeks
Immunogenicity
Time Frame: 52 weeks
Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum
52 weeks
Optimal Dose
Time Frame: 52 weeks
To determine the optimal dose of IVT ABI-110 injection for later phases of study
52 weeks
Pharmacokinetics and Pharmacodynamics
Time Frame: 52 weeks
Changes in PK and PD by ABI-110 dose level
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avirmax Biopharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

January 13, 2027

Study Completion (Estimated)

January 16, 2031

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Avirmax ABI-110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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