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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
Sponsor
GenEditBio Limited
Phase
Phase 1/2
Started
2026-10
Last updated
2026-09-10

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

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)

Trial sites (2)

FacilityCityRegionStatus
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