Fuchs Endothelial Corneal DystrophyPhase 2NCT07024693
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
A Phase 2 study testing DT-168 in people with Fuchs Endothelial Corneal Dystrophy and Fuchs, run by Design Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Fuchs Endothelial Corneal Dystrophy, Fuchs
- What is being tested?
- DT-168
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
- Known contraindication, allergy, or hypersensitivity to any of the treatments, anesthetics, or diagnostic agents or components thereof which may be used during the study.
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- 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 investigational interventional clinical study.
- Female participant is pregnant, planning a pregnancy, or breast-feeding.
- Participant is unwilling to comply with the contraceptive requirements, as per protocol.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
DTX-168-201 Study Site
Grand Rapids, Michigan, 49546
- Recruiting
DTX-168-201 Study Site
Indianapolis, Indiana, 46260
About this study
Official title: 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
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.
- Conditions
- Fuchs Endothelial Corneal Dystrophy, Fuchs
- Being tested
- DT-168
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT-168Drug
Active
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Drug: DT-168 Receives: Drug: DT-168 |
What is being measured
The primary outcome is the main question the study is designed to answer.
FECD Biomarkers: Splicing Panel
Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.
Measured: Perioperative
Secondary outcomes (1)
Safety and Tolerability
Frequency of treatment-emergent adverse events
Measured: Through study completion, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start30 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Design Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024693
- Sponsor's protocol ID
- DTX-168-201
- Status last verified
- Sep 2026
- First submitted
- 20 May 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07024693
- Acronym / sponsor ID
- DTX-168-201
- Conditions
- Fuchs Endothelial Corneal Dystrophy, Fuchs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Design Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DT-168Drug: DT-168 |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
- Concurrent use with Rhopressa®, Rocklatan®, or any other ocular Rho Kinase inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT-168Active | Drug | Active |
Primary outcome
FECD Biomarkers: Splicing Panel
Time frame: Perioperative
Assessment of DT-168 on splicing patterns in genes that are known to be disrupted in FECD.
1 secondary outcome
Safety and Tolerability
Time frame: Through study completion, an average of 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Fuchs Endothelial Corneal Dystrophy
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
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Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DT-168 in people with Fuchs Endothelial Corneal Dystrophy and Fuchs, run by Design Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Daniels (858-293-4948, mark@designtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FECD Biomarkers: Splicing Panel (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.