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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: f
View:
• 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.
Locations
United States
Indiana
DTX-168-201 Study Site
RECRUITING
Indianapolis
Michigan
DTX-168-201 Study Site
NOT_YET_RECRUITING
Grand Rapids
Contact Information
Primary
Mark Daniels
mark@designtx.com
858-293-4948
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 28
Treatments
Experimental: Active
Drug: DT-168
Related Therapeutic Areas
Sponsors
Leads: Design Therapeutics, Inc.