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Gene Therapy Trial Report

Summary

Gene Therapy for DME


NCTID NCT06492876 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Diabetic Macular Edema
Disease Ontology Term DOID:9191
Compound Name FT-003
Sponsor Frontera Therapeutics
Funder Type Industry
Recruitment Status
Enrollment Count 78 (ESTIMATED)
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