Gene therapy for diabetic macular edema
A Dose-escalation and Dose-expanded Phase I/II Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With DME
This study is testing a new gene therapy injection to see if it can improve vision and eye health in people with diabetic macular edema.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Frontera Therapeutics Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin,China) |
| Trial ID | NCT06492876 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-74 who have been clinically diagnosed with center-involved diabetic macular edema and have a specific range of visual acuity.
Not a fit: Patients with other intraocular diseases that could affect visual acuity or require treatment during the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from diabetic macular edema.
How similar studies have performed: While gene therapy for eye conditions is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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: +86-021-58206061
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.