A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty
Design Therapeutics, Inc.
Summary
The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study. * ≥30 years of age (inclusive). * Documented diagnosis of FECD in the study eligible eye. * Confirmation of positive TCF4 allele 18.1 CTG expansion in at least one allele. * Capable of giving signed informed consent. Exclusion Criteria: * Any ocular or medical condition in the study eligible eye which is clinically significant or would confound study results or data interpretation. * Any clinically significant medical, nonmedical, and psychiatric disorders that could pu…
Interventions
- DrugDT-168
Active
Locations (2)
- DTX-168-201 Study SiteIndianapolis, Indiana
- DTX-168-201 Study SiteGrand Rapids, Michigan