DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
NCT ID: NCT07024693
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
28 participants
INTERVENTIONAL
2025-07-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
Drug: DT-168
DT-168
Active
Interventions
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DT-168
Active
Eligibility Criteria
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Inclusion Criteria
* ≥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 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.
30 Years
ALL
No
Sponsors
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Design Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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DTX-168-201 Study Site
Indianapolis, Indiana, United States
DTX-168-201 Study Site
Grand Rapids, Michigan, United States
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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DTX-168-201
Identifier Type: -
Identifier Source: org_study_id