Gene Therapy for Diabetic Macular Edema - Trial NCT05916391
Access comprehensive clinical trial information for NCT05916391 through Pure Global AI's free database. This Phase 1 trial is sponsored by Frontera Therapeutics and is currently Recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 18 participants.
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Study Focus
Sponsor & Location
Frontera Therapeutics
Timeline & Enrollment
Phase 1
May 19, 2023
May 01, 2028
Primary Outcome
Safety and tolerability after FT-003 injection
Summary
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic
 macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular
 complications of diabetes mellitus, and diabetic macular edema is the main cause of vision
 loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is
 preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing
 intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to
 reduce the current treatment burden which often results in undertreatment and vision loss in
 patients with CI-DME receiving anti-VEGF therapy in clinical practice.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05916391
Non-Device Trial