Status:
RECRUITING
Gene Therapy for DME
Lead Sponsor:
Frontera Therapeutics
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
PHASE2
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 int...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06492876
Start Date
November 15 2023
End Date
November 15 2028
Last Update
July 9 2024
Active Locations (1)
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1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, China, 300392