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Clinical Trial Report

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
Recruiting
Enrollment Count 18
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
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2024-07-25
Completion Date 2030-02
Last Update 2024-10-02

Participation Criteria


Eligible Age 50 Years - 89 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

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