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A Phase 2, Multicenter, Open-Label Study to Assess the Pharmacodynamics, Safety, and Tolerability of DT-168 Ophthalmic Solution in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Keratoplasty
Led by Design Therapeutics, Inc. · Updated on 2025-12-29
28
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in patients diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD) who are scheduled for keratoplasty. The study focuses on individuals aged 30 years or older with a documented FECD diagnosis and positive TCF4 allele expansion, assessing how this treatment interacts with the condition before surgery. Participants will receive DT-168 as the active treatment during the trial. This open-label, Phase 2 study is multicenter and involves monitoring patients undergoing keratoplasty, which is the surgical management for FECD. The trial will observe participants through the treatment period, focusing on perioperative biomarker changes and safety endpoints. During the study, participants will undergo assessments related to FECD biomarkers using a splicing panel around the time of surgery. Safety and tolerability will be monitored continuously throughout the average four-week study duration. Researchers will collect data to understand the drug's effects and any adverse reactions, ensuring close observation of participants' health and responses to the treatment.
CONDITIONS
Brief Title
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is scheduled to undergo a keratoplasty for management of FECD independent of this study.
- 30 years of age or older.
- 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.
You will not qualify if you...
- 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.
- Concurrent or anticipated need for treatment for FECD, such as Muro 128 (2% or 5%) during the study in the study eye, unless washed out for at least 24 hours before baseline visit.
- 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 treatments, anesthetics, or diagnostic agents used during the study.
- Use of contact lenses in the study eye within 7 days prior to baseline visit or planned use during the study.
- Recent or ongoing participation in another investigational interventional clinical study within 30 days prior to screening.
- Female participant is pregnant, planning a pregnancy, or breastfeeding.
- Participant is unwilling to comply with the contraceptive requirements per protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive the investigational drug DT-168 as part of their keratoplasty procedure and the perioperative period to assess pharmacodynamics, safety, and tolerability.
1 baseline visit and multiple perioperative visits
Trial Site Locations
Total: 2 locations
1
DTX-168-201 Study Site
Indianapolis, Indiana, United States, 46260
Actively Recruiting
2
DTX-168-201 Study Site
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
Research Team
M
Mark Daniels
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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