DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Recruiting now · Phase 2

Conditions studied: Fuchs Endothelial Corneal Dystrophy, Fuchs

In brief

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.

Key facts

Study ID

NCT07024693

Run by

Design Therapeutics, Inc.

People needed

28

Starts

2025-07-30

Expected to finish

2026-12-01

Last updated by the study team

2025-12-29

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 put the participant at higher risk for participation in the study, impair the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
• Concurrent or anticipated need for treatment for FECD, eg, Muro 128 (2% or 5%) during the course of the study in the study eye. Provided the subject undergoes a washout of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
• Concurrent or anticipated use of topical corticosteroids in the study eye.
• Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
• Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
• Use of contact lenses in the study eye within 7 days prior to the Baseline Visit or planned use during the study.
• Recent (within 30 days of the Screening Visit) or ongoing participation in any other investigational interventional clinical study.
• Female participant is pregnant, planning a pregnancy, or breast-feeding.
• Participant is unwilling to comply with the contraceptive requirements, as per protocol.

Where it is running

• DTX-168-201 Study Site — Indianapolis, Indiana, United States (enrolling)
• DTX-168-201 Study Site — Grand Rapids, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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