Safety and Efficacy Study of GEB-101 Injection in Subjects With TGFBI-related Corneal Dystrophy
Starting soon · Phase 1/Phase 2
Conditions studied: Hereditary Corneal Dystrophy, Corneal Abnormality, Corneal Dystrophies, Corneal Dystrophies, Hereditary
In brief
The goal of this clinical trial is to evaluate the safety and efficacy of GEB-101 injection in subjects with TGFBI-related Corneal Dystrophy
Key facts
- Study ID
- NCT07750678
- Run by
- GenEditBio Limited
- People needed
- 30
- Starts
- 2026-08-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males or females, age 18-70 years (inclusive).
- TGFBI gene mutation confirmed.
- Patients with corneal dystrophy who are symptomatic.
- Willing and able to give signed informed consent and follow study instructions.
You may not qualify if…
- In either eye: Have any active infection, glaucoma, corneal disease, or other ocular conditions that may affect the assessment of efficacy or safety.
- In the study eye: Have a history of specific intraocular or corneal surgery, or the presence of active intraocular inflammation or vitreous hemorrhage.
- Patient with other corneal disorders that may hinder therapeutic surgery or interfere with the interpretation of study results.
- Prior gene therapy administration in either eye.
- Active infection occurring or suspected within 4 weeks prior to the investigational product, requiring systemic anti-infective therapy.
- Subjects with a history of major cardiovascular events within 6 months, the presence of any clinically significant condition, a diagnosis of malignancy within 5 years (with specified exceptions), or active infection with HIV, syphilis, hepatitis C, or hepatitis B.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol.
Where it is running
- University of California, Los Angeles (UCLA) — Los Angeles, California, United States
- Fudan University Eye & ENT Hospital — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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