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Gene Therapy Trial Browser
Clinical Trial Report
Gene Therapy Trial Report
Summary
Gene Therapy for DME
NCTID
NCT06492876
(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 Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
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Development Status
Active
Indication
Diabetic Macular Edema
Disease Ontology Term
DOID:9191
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
2028-11-15
Last Update
2024-07-09
Participation Criteria
Eligible Age
18 Years - 74 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
IND cleared 12/30/24
Resources/Links
News and Press Releases
Frontera Therapeutics Receives FDA Clearance for Phase 2 Clinical Trial of FT-003 for Diabetic Macular Edema (DME)
A first in China: Frontera Therapeutics Doses First Patient in a Clinical Trial of FT-003 Gene Therapy for the Treatment of DME
Related NCTID
Phase 1: NCT05916391