ClinicalTrials.gg
RecruitingNCT07024693Updated Sep 28, 2026

DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy

A Phase 2 interventional study of DT-168 in Fuchs Endothelial Corneal Dystrophy and Fuchs, sponsored by Design Therapeutics, Inc.. Recruiting at 2 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Design Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Updated Sep 28, 2026Primary completion movedStudy completion moved+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
30 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Fuchs Endothelial Corneal Dystrophy
  • Fuchs
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's planned enrollment of 70 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Design Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Any ocular or medical condition in the study eligible eye which is 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 of Muro drops for at least 24 hours prior to the Baseline Visit, they will not be excluded.
  • Concurrent or anticipated use of topical in the study eye.
  • Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
  • Known , allergy, or 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 interventional clinical study.
  • Female participant is pregnant, planning a pregnancy, or breast-feeding.
  • Participant is unwilling to comply with the requirements, as per protocol.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Active

    Drug: DT-168

    Drug: DT-168

Interventions

  • DrugDT-168

    Active

06

What researchers measure

Primary outcomes

  1. 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

  1. Safety and Tolerability

    Frequency of treatment-emergent adverse events

    Time frame: Through study completion, an average of 4 weeks.

07

Study locations

2 of 2 sites recruiting
  • DTX-168-201 Study Site
    Indianapolis, Indiana 46260, United States
    Recruiting
  • DTX-168-201 Study Site
    Grand Rapids, Michigan 49546, United States
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 2026→Dec 2027
Sep 28, 2026
Study completion
Dec 2026→Dec 2027
Sep 28, 2026
Enrollment
28→70
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Primary completion Sep 2026→Dec 2027
    Study completion Dec 2026→Dec 2027
    Enrollment 28→70
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07024693
Lead sponsor
Design Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 17, 2025
Start date
Jul 30, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Mark Daniels
Contact
mark@designtx.com
858-293-4948

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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