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. (Show More)
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 (Click here for study contact information)
Enrollment Count	78 (ESTIMATED)
Results Posted	Not Available

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
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

Eligible Age	18 Years - 74 Years
Standard Ages	Adult, Older adult
Sexes Eligible for Study	ALL
Eligibility Criteria	Inclusion Criteria: * Subjects that are willing and able to follow study procedures; * Female or male patients 18-74 years old at the time of signing the ICF; * Clinically diagnosed with CI-DME; * The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters; Exclusion Criteria: * Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator. View Inclusion and Exclusion Criteria at ClinicalTrials.gov

No.of Trial Sites	1
Locations	China