DT-168 for people with Fuchs endothelial corneal dystrophy who are having a corneal transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study administers DT-168 ophthalmic solution to patients with Fuchs endothelial corneal dystrophy who are scheduled to undergo keratoplasty, with the goal of characterizing pharmacodynamics, safety, and tolerability. Eligible participants must be at least 30 years old, have a documented diagnosis of FECD in the study eye, and carry a confirmed TCF4 allele CTG expansion. Treatments are given in the pre-keratoplasty period with regular in-person assessments for ocular measurements, pharmacodynamic sampling, and safety monitoring at study visits. Keratoplasty is performed as planned independent of study participation, and outcomes focus on corneal pharmacodynamic markers, adverse events, and participant-reported tolerability.

Why it matters

Who can join: the full rules

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.

Where it's running

• DTX-168-201 Study Site
  Indianapolis, Indiana, United States Recruiting
• DTX-168-201 Study Site
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Mark Daniels
• Email: mark@designtx.com
• Phone: 858-293-4948

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Observing outcomes of posterior lamellar keratoplasty for eye conditions

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.