RecruitingPhase 1Phase 2NCT06492876

Gene Therapy for DME

A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME

Sponsor

Frontera Therapeutics

Enrollment

78 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Diabetic Macular Edema

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 74 Years

Inclusion Criteria4

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 Criteria1

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.

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