Phase 2 Study of DT-168 Eye Drops for Safety and Effects in Patients Aged 30 and Over With Fuchs Endothelial Corneal Dystrophy Undergoing Corneal Transplant Surgery

What this Trial Is About

This research aims to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in patients diagnosed with Fuchs Endothelial Corneal Dystrophy FECD who are scheduled for keratoplasty. The study focuses on individuals aged 30 years or older with a documented FECD diagnosis and positive TCF4 allele expansion, assessing how this treatment interacts with the condition before surgery. Participants will receive DT-168 as the active treatment during the trial. This open-label, Phase 2 study is multicenter and involves monitoring patients undergoing keratoplasty, which is the surgical management for FECD. The trial will observe participants through the treatment period, focusing on perioperative biomarker changes and safety endpoints. During the study, participants will undergo assessments related to FECD biomarkers using a splicing panel around the time of surgery. Safety and tolerability will be monitored continuously throughout the average four-week study duration. Researchers will collect data to understand the drugs effects and any adverse reactions, ensuring close observation of participants health and responses to the treatment.

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy