Clinical Trials in the USA / NCT07750678
Starting soon
Phase 1/2
Safety and Efficacy Study of GEB-101 Injection in Subjects With TGFBI-related Corneal Dystrophy
NCT07750678 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hereditary Corneal DystrophyCorneal AbnormalityCorneal DystrophiesCorneal Dystrophies, Hereditary
Investigational drug(s) / intervention(s)
GEB-101 Injection
GEB-101 Injection: Single intrastromal injection
Study summary
The goal of this clinical trial is to evaluate the safety and efficacy of GEB-101 injection in subjects with TGFBI-related Corneal Dystrophy
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Incidence of DLTs — 30 Days
Number and proportion of dose limited toxicity(DLTs) - Incidence of AEs — 360 Days
Number and severity of overall and ocular and systemic adverse events (AEs) - Incidence of SAEs — 360 Days
Number and severity of overall and ocular and systemic serious adverse events (SAEs)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Los Angeles (UCLA) | Los Angeles | California | |
| Fudan University Eye & ENT Hospital | Shanghai | Shanghai Municipality |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07750678 on ClinicalTrials.gov ↗ ← All trials in the USA