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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2026
This is a Phase 1/2 seamless, adaptive, multi‐center, sequential study evaluates thesafety and efficacy of GEB‐101 in adult participants with TGFBI‐related cornealdystrophy.The Phase 1 part is a single‐arm, open‐label, dose‐escalation study with three plannedcohorts , followed by 2 expansion cohorts at the recommended Phase 2 dose.The Phase 2 transitions to a randomized, double‐blind, vehicle‐controlled,self‐controlled design.After completing the primary 1‐year follow‐up, a long‐term follow‐up will be proposed toall the participants who received GEB‐101 treatment, with close in site follow‐upconducted from Year 2 to Year 5, followed by telephone or questionnaire‐based follow‐upuntil Year 15.
Epistemonikos ID: 273be8ac3975abd1a85803f296639c45b78d7fd1
First added on: Aug 07, 2026