Gene Therapy for DME
Phase 1
Recruiting
- Conditions
- Diabetic Macular Edema
- Interventions
- Genetic: FT-003
- Registration Number
- NCT06492876
- Lead Sponsor
- Frontera Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description FT003 Dose 1 FT-003 Low dose of FT-003 FT003 Dose 3 FT-003 High dose of FT-003 FT003 Dose 2 FT-003 Mid dose of FT-003
- Primary Outcome Measures
Name Time Method Safety and tolerability after FT-003 injection At Week 12 Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy after FT-003 injection At Week 24 the BCVA /CST change from baseline
Trial Locations
- Locations (1)
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, Tianjin,China, China