DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

Launched by DESIGN THERAPEUTICS, INC. · Jun 9, 2025

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ClinConnect Summary

This clinical trial is studying a new eye drop called DT-168 to see if it is safe and works well for people with Fuchs Endothelial Corneal Dystrophy (often called Fuchs), a condition that affects the clear front part of the eye and can lead to vision problems. The study is for patients who are planning to have a corneal transplant surgery (called keratoplasty) to treat their Fuchs. The goal is to learn how the eye drop affects the eye before surgery and to check for any side effects.

People who might be eligible to join this study are adults aged 30 or older who have been diagnosed with Fuchs in one eye and who have a specific genetic marker related to the disease. They must already be scheduled for corneal transplant surgery but haven’t started certain other eye medications, like steroid drops or other specific glaucoma medicines. Participants will need to give informed consent, and women who are pregnant, planning to become pregnant, or breastfeeding cannot join. If you take part, you can expect to have your eye health closely monitored while using the study eye drops before your planned surgery. This trial is not yet open for enrollment.

Gender

ALL

Eligibility criteria

• 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.