RECRUITING

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

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.

Study Overview

Study Details

Study overview

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.

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

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Condition
Fuchs Endothelial Corneal Dystrophy
Intervention / Treatment

-

Contacts and Locations

Indianapolis

DTX-168-201 Study Site, Indianapolis, Indiana, United States, 46260

Grand Rapids

DTX-168-201 Study Site, Grand Rapids, Michigan, United States, 49546

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

30 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Design Therapeutics, Inc.,

Study Record Dates

2026-12