DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

ConditionsFuchs Endothelial Corneal Dystrophy Fuchs

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

DT-168
Drug
Active

Treatment groups

70 Participants

are divided into 1 treatment group

Group A: ActiveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

FECD Biomarkers: Splicing Panel

Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.

Time frame

Perioperative

Secondary outcomes

Safety and Tolerability

Frequency of treatment-emergent adverse events

Time frame

Through study completion, an average of 4 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Design Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

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