Actively Recruiting
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Led by Design Therapeutics, Inc. · Updated on 2025-12-29
28
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is scheduled to undergo keratoplasty for Fuchs Endothelial Corneal Dystrophy
- 30 years of age or older
- Documented diagnosis of FECD in the study eye
- Positive TCF4 allele 18.1 CTG expansion in at least one allele
- Able to provide signed informed consent
You will not qualify if you...
- Any significant ocular or medical condition in the study eye that could affect study results
- Any serious medical, psychiatric, or nonmedical disorder that could increase risk or interfere with participation
- Need for FECD treatments like Muro 128 during the study (unless washed out 24 hours before baseline)
- Use of topical corticosteroids in the study eye
- Use of Rhopressa, Rocklatan, or other ocular Rho Kinase inhibitors
- Known allergy or hypersensitivity to study treatments or agents used
- Use of contact lenses in the study eye within 7 days before baseline or planned use during study
- Participation in another investigational study within 30 days before screening
- Female participants who are pregnant, planning pregnancy, or breastfeeding
- Unwillingness to follow contraceptive requirements as per protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
DTX-168-201 Study Site
Indianapolis, Indiana, United States, 46260
Actively Recruiting
2
DTX-168-201 Study Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
Research Team
M
Mark Daniels
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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