Gene therapy for diabetic macular edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, tolerability, and efficacy of a gene therapy treatment called FT-003 administered through a vitreous injection in patients with diabetic macular edema (DME). The study is structured in two phases: a Phase 1 dose escalation to determine the appropriate dosage and a Phase 2 dose expansion to further evaluate its effects. Participants will be monitored for improvements in visual acuity and overall eye health throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Tianjin Medical University Eye Hospital
  Tianjin, Tianjin,China, China Recruiting

Study contacts

• Principal investigator: Xiaorong Li, Professor — Tianjin Medical University Eye Hospital
• Study coordinator: Xinyan Li
• Email: Xinyan.li@fronteratherapeutics.com
• Phone: +86-021-58206061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.