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DT-168 for Fuchs Endothelial Corneal Dystrophy Before Keratoplasty

This study is looking at a drug called DT-168 Ophthalmic Solution for people with Fuchs endothelial corneal dystrophy (FECD) who are planning to have a keratoplasty (cornea transplant). The main goal is to understand how DT-168 works in your body, how safe it is, and if you can tolerate it. You might be able to join if you are at least 30 years old, have FECD, and are already scheduled for a keratoplasty. You also need to have a specific genetic marker (TCF4 allele 18.1 CTG expansion). Researchers will measure FECD biomarkers (splicing panel) around the time of your surgery to see if the drug is having an effect. The study plans to enroll 28 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 28 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure FECD biomarkers at the time of your surgery (perioperative).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07024693

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Recruiting
PHASE2Ages 30+InterventionalTreatment
Design Therapeutics, Inc.
~28 participants
Updated 2025-12-29 on ClinicalTrials.gov
What's tested:DT-168

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
FECD Biomarkers: Splicing Panel
Measured over Perioperative

Conditions

Fuchs Endothelial Corneal Dystrophy
Fuchs

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Where it's being run

2 sites across 2 states
Indiana1
Michigan1

Who to contact

Mark Daniels
[email protected]
858-293-4948
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • FECD Biomarkers: Splicing PanelPerioperative

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