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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
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