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DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy | Clinical Trials | Clareo Health

RECRUITINGPHASE2

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

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

NCT07024693•Design Therapeutics, Inc.

View on ClinicalTrials.gov

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

30 - No limit years

Sex

ALL

Healthy Volunteers

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 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.

Locations (2)

DTX-168-201 Study Site

Indianapolis, Indiana, United States

DTX-168-201 Study Site

Grand Rapids, Michigan, United States

Key Dates

Start Date

July 30, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2026

Last Updated

December 29, 2025

Enrollment

ESTIMATED participants

Conditions

Fuchs Endothelial Corneal DystrophyFuchs

Interventions

DT-168

DRUG

Contacts

Mark Daniels

CONTACT

858-293-4948 mark@designtx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Inclusion Criteria

Exclusion Criteria

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