Actively Recruiting
Gene Therapy for Diabetic Macular Edema
Led by Frontera Therapeutics · Updated on 2023-06-23
18
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
F
Frontera Therapeutics
Lead Sponsor
T
Tianjin Medical University Eye Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.
CONDITIONS
Official Title
Gene Therapy for Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to follow study procedures
- Male or female patients aged 18 years or older at the time of signing informed consent
- Clinically diagnosed with central involvement diabetic macular edema (CI-DME)
- HbA1c of 10% or less
- Best corrected visual acuity of 73 letters or less in the studied eye
You will not qualify if you...
- Presence of any other intraocular diseases besides CI-DME in the studied eye that would affect visual acuity 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
Minghui Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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