Gene Therapy for DME

Recruiting now · Phase 1/Phase 2

Conditions studied: Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT06492876

Run by

Frontera Therapeutics

People needed

78

Starts

2023-11-15

Expected to finish

2028-11-15

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• Tianjin Medical University Eye Hospital — Tianjin, Tianjin,China, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.