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)

NCT06550011 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: Avirmax ABI-110
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Neovascular (Wet) AMD

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  52 weeks

Secondary Outcomes (4)

• Preliminary Efficacy

  52 weeks

• Pharmacokinetics and Pharmacodynamics

  52 weeks

• Immunogenicity

  52 weeks

• Optimal Dose

  52 weeks

Study Arms (3)

Dose level 1

EXPERIMENTAL

Low Dose

Drug: ABI-110 Low Dose

Dose level 2

EXPERIMENTAL

Medium Dose

Drug: ABI-110 Medium Dose

Dose level 3

EXPERIMENTAL

High Dose

Drug: ABI-110 High Dose

Interventions

ABI-110 Low Dose DRUG

Low dose. lower than the safety factor of 10 as recommended by the FDA

Dose level 1

ABI-110 Medium Dose DRUG

Medium dose

Dose level 2

ABI-110 High Dose DRUG

High Dose

Dose level 3

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• Must be willing and able to provide written, signed informed consent.
• Age: Subjects ≥ 50 and ≤ 89 years of age at the time of signing the informed consent
• Study eye:
• Diagnosis of wAMD, including symptomatic macular PCV, confirmed by the Central Reading Center
• The macular neovascularization lesion must be confirmed as determined by the Central Reading Center based on SD-OCT imaging at screening.
• BCVA ≤ 20/25 and ≥ 20/250 (≤ 80L and ≥ 30L ETDRS letters)
• History of ≥ 2 anti-VEGF injections prior to trial entry with meaningful response to anti-VEGF and continued need for anti-VEGF treatment
• Response to anti-VEGF at trial entry

You may not qualify if:

• Study or Fellow Eye:
• Prior gene therapy, either eye
• 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
• History of retinal disease other than wAMD or PCV, study eye
• Any condition preventing visual acuity improvement (e.g., fibrosis, atrophy, or retinal epithelial tear in the center of the fovea), study eye.
• History of (or active) retinal detachment, study eye
• Uncontrolled glaucoma (defined as IOP \> 25 mmHg despite treatment), study eye, or history of steroid-response ocular hypertension/glaucoma in either eye
• 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
• Any prior treatment with photodynamic therapy or laser photocoagulation, study eye
• History of glaucoma filtration, vitrectomy, or other procedure that could affect drug distribution or clearance, study eye.

Sponsors & Collaborators

• Avirmax Biopharma Inc: lead

Study Sites (4)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Texas - San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose Escalation

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 12, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): January 16, 2031
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)