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NCT05916391

Gene Therapy for Diabetic Macular Edema

An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
Frontera Therapeutics·Phase 1·ClinicalTrials.gov·geneticRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
FT-003
Study type
Interventional
Intervention type
genetic
Sponsor & location
Primary sponsor
Frontera Therapeutics
Location
Tianjin, China
Timeline & enrollment
Phase
Phase 1
Start date
May 19, 2023
End date
May 01, 2028
Enrollment
18 participants
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
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05916391
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.