RECRUITING

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Conditions

Fuchs Endothelial Corneal Dystrophy Fuchs

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07024693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mark Daniels

CONTACT

858-293-4948

mark@designtx.com

Study Locations (Sites)

DTX-168-201 Study Site

Indianapolis, Indiana, 46260

United States

DTX-168-201 Study Site

Grand Rapids, Michigan, 49546

United States

Collaborators and Investigators

Sponsor: Design Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Fuchs Endothelial Corneal Dystrophy
Fuchs