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New treatment option for Fuchs Endothelial Corneal Dystrophy
Official title DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
ClinicalTrials.gov ID: NCT07024693
What this study is testing
What is DT-168?
DT-168 is an investigational medicine, being studied as a potential treatment for fuchs endothelial corneal dystrophy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
- 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 treatment clinical study.
- Female participant is pregnant, planning a pregnancy, or breast-feeding.
- Participant is unwilling to comply with the contraceptive requirements, as per protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Grand Rapids, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Grand Rapids, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.