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. (Show More)
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 (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	6E10 vg/eye
Dose 2	1.2E11 vg/eye
Dose 3	2.4E11 vg/eye

Eligible Age	50 Years - 80 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 50-80 years old at the time of signing the ICF; * Clinically diagnosed with nAMD; * Presence of active CNV * The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters; Exclusion Criteria: * •Presence of any other intraocular diseases other than nAMD 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

Has US IND	False
FDA Designations
Recent Updates	FDA clearance for Phase 2 trial received 11/11/24