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)

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: Neovascular (Wet) AMD
• Intervention / Treatment: Drug: ABI-110 Low Dose; Drug: ABI-110 Medium Dose; Drug: ABI-110 High Dose

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

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

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Efficacy	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	Changes in Anti-AAV2 antibodies (ADA) and anti-VEGF-Trap antibodies in serum	52 weeks
Optimal Dose	To determine the optimal dose of IVT ABI-110 injection for later phases of study	52 weeks
Pharmacokinetics and Pharmacodynamics	Changes in PK and PD by ABI-110 dose level	52 weeks

Collaborators and Investigators

• Sponsor: Avirmax Biopharma Inc

Study record dates

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: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Neovascularization, Pathologic; Choroidal Neovascularization; Macular Degeneration; Polypoidal Choroidal Vasculopathy
• 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