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 evaluates FT-003, a gene therapy product aimed at treating central involvement diabetic macular edema (CI-DME), a leading cause of vision loss in diabetic patients. The therapy seeks to provide a durable intraocular protein expression that could reduce the treatment burden associated with current anti-VEGF therapies. By potentially improving visual acuity and reducing the frequency of treatments, FT-003 aims to enhance patient outcomes in managing CI-DME.

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 years old at the time of signing the ICF;
* Clinically diagnosed with CI-DME
* HbA1c≤10%
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters

Exclusion Criteria:

* Presence of any other intraocular diseases other than CI-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: +862158206061

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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.