Gene therapy for diabetic macular edema
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
This study is testing a new gene therapy to see if it can help people with diabetic macular edema improve their vision and reduce the number of treatments they need.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Frontera Therapeutics Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin,China) |
| Trial ID | NCT05916391 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been clinically diagnosed with central involvement diabetic macular edema and meet specific health criteria.
Not a fit: Patients with other intraocular diseases that could affect visual acuity improvement will not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve vision and reduce the treatment burden for patients with diabetic macular edema.
How similar studies have performed: While gene therapy for eye conditions is an emerging field, this specific approach for diabetic macular edema is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin, Tianjin,China
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.