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Gene Therapy Trial Report

Summary

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)


NCTID NCT06550011 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term DOID:10871
Compound Name ABI-110
Compound Description AAV2.N54-VEGF-Trap
Sponsor Avirmax Biopharma Inc
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 18 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant VEGFtrap
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intravitreal
Drug Product Type Viral vector
Target Tissue/Cell Macula
Delivery System Viral transduction
Vector Type AAV.N54
Editor Type none
Dose 1 Undisclosed low dose
Dose 2 Undisclosed medium dose
Dose 3 Undisclosed high dose

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2024-07-25
Completion Date 2031-01-16
Last Update 2026-02-12

Participation Criteria


Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL
Eligibility Criteria
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.
View Inclusion and Exclusion Criteria at ClinicalTrials.gov

Locations


No.of Trial Sites 4
Locations United States

Regulatory Information


Has US IND True
FDA Designations
Recent Updates First cohort completion announced February 2025

Resources/Links