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

Not Yet RecruitingPhase 1, Phase 2

Sponsor: GenEditBio Limited

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

Interventions: GEB-101 Injection

Countries: United States, China

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (2)

Los Angeles, California, United States
Shanghai, Shanghai Municipality, China