DT-168 for Fuchs' Dystrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new eye drop called DT-168 to evaluate its safety and effectiveness for individuals with Fuchs' endothelial corneal dystrophy, a condition where the inner layer of the cornea deteriorates. The goal is to assist those planning to undergo a corneal transplant due to this condition. The trial seeks participants diagnosed with Fuchs' dystrophy who are scheduled for corneal transplant surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eye care.
Will I have to stop taking my current medications?
You may need to stop using certain eye medications like Muro 128, topical corticosteroids, and Rho Kinase inhibitors before joining the study. Specifically, if you're using Muro 128, you'll need to stop at least 24 hours before the baseline visit.
Is there any evidence suggesting that DT-168 is likely to be safe for humans?
Research has shown that DT-168, an eye drop treatment for Fuchs' dystrophy, was safe in earlier studies. Tests with healthy volunteers reported no serious side effects or eye problems. This suggests the treatment is generally safe for people. Currently, DT-168 is being tested in patients awaiting corneal transplants. This ongoing study aims to further confirm its safety and tolerability.12345
Why do researchers think this study treatment might be promising?
DT-168 is unique because it introduces a new approach to treating Fuchs' Dystrophy compared to traditional options like corneal transplants and Descemet membrane endothelial keratoplasty (DMEK). Unlike these surgical methods, which replace damaged corneal tissue, DT-168 is an experimental drug that aims to enhance cellular function and potentially restore the health of existing corneal cells. Researchers are excited about DT-168 because it targets the underlying cellular dysfunction, offering a less invasive and more targeted treatment option that could improve patient outcomes and reduce the need for complex surgeries.
What evidence suggests that DT-168 might be an effective treatment for Fuchs' dystrophy?
Research has shown that DT-168, the investigational treatment in this trial, has potential in early studies for treating Fuchs' endothelial corneal dystrophy. In lab tests, DT-168 reduced harmful cell clusters to levels similar to those in healthy cells, suggesting the drug might help restore the function of the corneal endothelium, a layer of cells on the eye's surface. Previous human trials demonstrated that DT-168 is well-tolerated and does not cause serious side effects. These findings offer hope for its effectiveness in treating Fuchs' dystrophy.12346
Are You a Good Fit for This Trial?
This trial is for adults over 30 with Fuchs endothelial corneal dystrophy (FECD) who are scheduled for keratoplasty. They must have a positive TCF4 allele and be able to consent. Pregnant or breastfeeding women, contact lens users, and those on topical steroids or other studies can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DT-168 Ophthalmic Solution and are assessed for pharmacodynamics, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DT-168
Find a Clinic Near You
Who Is Running the Clinical Trial?
Design Therapeutics, Inc.
Lead Sponsor