Actively Recruiting
Gene Therapy for DME
Led by Frontera Therapeutics · Updated on 2024-07-09
78
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Gene Therapy for DME
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow study procedures
- Female or male patients aged 18 to 74 years at time of consent
- Clinically diagnosed with center-involved Diabetic Macular Edema (CI-DME)
- Best corrected visual acuity (BCVA) of the studied eye between 24 and 73 letters
You will not qualify if you...
- Presence of any other intraocular diseases in the studied eye besides DME that could affect visual improvement or require treatment during the study, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Eye Hospital
Tianjin, Tianjin,China, China, 300392
Actively Recruiting
Research Team
X
Xinyan Li
CONTACT
M
Mignhui Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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