NCT07024693 · Design Therapeutics, Inc.
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
What this study is about
The purpose of this study is to evaluate the how the drug affects the body, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.
View original scientific description
The purpose of this study is to evaluate the pharmacodynamics, safety, and tolerability of DT-168 Ophthalmic Solution in pre-keratoplasty patients with Fuchs endothelial corneal dystrophy.
Interventions
DRUG
DT-168
Active
Primary outcome measures
FECD Biomarkers: Splicing Panel
Time frame: Perioperative
Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 washo
Where
- Indianapolis, Indiana
- Grand Rapids, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 29, 2025 · Source of record for eligibility and locations