DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

NCT07024693 | Recruiting Phase 2 FDA Drug

• 1 other identifier: DTX-168-201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fuchs Endothelial Corneal Dystrophy; Fuchs

Outcome Measures

Primary Outcomes (1)

• FECD Biomarkers: Splicing Panel

  Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.

  Perioperative

Secondary Outcomes (1)

• Safety and Tolerability

  Through study completion, an average of 4 weeks.

Study Arms (1)

Active

EXPERIMENTAL

Drug: DT-168

Drug: DT-168

Interventions

DT-168 DRUG

Active

Active

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Design Therapeutics, Inc.: lead

Study Sites (2)

DTX-168-201 Study Site

Indianapolis, Indiana, 46260, United States

RECRUITING

DTX-168-201 Study Site

Grand Rapids, Michigan, 49546, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mark Daniels

CONTACT

858-293-4948; mark@designtx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 17, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

US (2)