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Gene Therapy Trial Browser
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
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.
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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
News and Press Releases
Avirmax Biopharma Announces Completion of the First Cohort of Patient Enrollment in Clinical Trial of ABI-110, a Gene Therapy for Wet AMD Including PCV