DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorDesign Therapeutics, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- DT-168
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov