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Not Yet Recruiting NCT07750678

Safety and Efficacy Study of GEB-101 Injection in Subjects With TGFBI-related Corneal Dystrophy

Conditions: Hereditary Corneal Dystrophy, Corneal Abnormality, Corneal Dystrophies, Corneal Dystrophies, Hereditary

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 30
Sponsor: GenEditBio Limited

Location: University of California, Los Angeles (UCLA) Los Angeles California

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07750678). StuddyBuddy aggregates publicly available trial information.