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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Gene Therapy(FT-003) for Wet AMD
NCTID
NCT06492863
(View at clinicaltrials.gov)
Description
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
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Development Status
Active
Indication
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
Disease Ontology Term
DOID:10871
Compound Name
FT-003
Sponsor
Frontera Therapeutics
Funder Type
Industry
Recruitment Status
Recruiting
Enrollment Count
78
Results Posted
Not Available
Therapy Information
Target Gene/Variant
Aflibercept
Therapy Type
Gene transfer
Therapy Route
In-vivo
Mechanism of Action
Genetic delivery of therapeutic protein
Route of Administration
Intravitreal
Drug Product Type
Viral vector
Target Tissue/Cell
Delivery System
Viral transduction
Vector Type
AAV2.7m8
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
2024-07-01
Completion Date
2028-10-15
Last Update
2024-07-09
Participation Criteria
Eligible Age
50 Years - 80 Years
Standard Ages
Adult, Older adult
Sexes Eligible for Study
ALL
Locations
No.of Trial Sites
1
Locations
China
Regulatory Information
Has US IND
False
FDA Designations
Recent Updates
FDA clearance for Phase 2 trial received 11/11/24
Resources/Links
News and Press Releases
Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of Wet AMD
FDA Frontera Receives FDA clearance for FT-003 Phase 2 IND in Neovascular Age-Related Macular Degeneration
Related NCTID
Phase 1: NCT05611424