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RECRUITING
NCT05916391
PHASE1

Gene Therapy for Diabetic Macular Edema

Sponsor: Frontera Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2023-05-19

Completion Date

2028-05-01

Last Updated

2023-06-23

Healthy Volunteers

No

Interventions

GENETIC

FT-003

Administration via intraocular injection

Locations (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin,China, China