Gene Therapy for DME
NCT06492876 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2024-07-09
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.
Conditions
Interventions
- GENETIC
-
FT-003
Administered via intraocular injection.
Sponsors & Collaborators
-
Frontera Therapeutics
lead INDUSTRY
Principal Investigators
-
Xiaorong Li, Professor · Tianjin Medical University Eye Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 74 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-15
- Primary Completion
- 2024-11-15
- Completion
- 2028-11-15
Countries
- China
Study Locations
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