Recruiting
Phase 2

DT-168

Sponsor:

Design Therapeutics, Inc.

Code:

NCT07024693

Conditions

Fuchs Endothelial Corneal Dystrophy

Fuchs

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

DT-168

Study Details

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

Study ID

NCT07024693

Start date

Jul 30, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

Drug: DT-168

Interventions

DT-168

Active

Primary outcome measure

  • FECD Biomarkers: Splicing Panel [ Time Frame: Perioperative ]

Central Contacts and Locations

Central contacts

Mark Daniels

858-293-4948mark@designtx.com

Locations

DTX-168-201 Study Site

Recruiting

Indianapolis, Indiana, United States, 46260

DTX-168-201 Study Site

Recruiting

Grand Rapids, Michigan, United States, 49546

More Information

Sponsor

Design Therapeutics, Inc.

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Design Therapeutics, Inc. on 2025-12-29.