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Ripasudil for Fuchs' Dystrophy (DETECT I Trial)

Phase 3

Recruiting

Led By Jennifer Rose-Nussbaumer, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Dysfunctional endothelium from prior graft failure after PKP or EK

Willingness and ability to undergo corneal transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 24 months

Awards & highlights

DETECT I Trial Summary

This trial is testing two types of corneal transplant surgeries and the effect of a rho-kinase inhibitor on visual outcomes and cell loss.

Who is the study for?

This trial is for adults over 18 with Fuchs' Dystrophy or other corneal diseases, who are good candidates for corneal transplant surgery and willing to follow the study's medication regimen. It excludes pregnant individuals, those with significant eye conditions in the non-study eye, recent cataract surgery, or inability to follow post-op instructions.Check my eligibility

What is being tested?

DETECT I evaluates visual outcomes of two corneal transplant surgeries (UT-DSAEK and DMEK) and examines if rho-kinase inhibitors can reduce cell loss after these procedures. Participants will be randomly assigned to receive either topical Ripasudil or a placebo in a masked setup.See study design

What are the potential side effects?

While specific side effects are not listed here, typical concerns may include irritation from topical medications like Ripasudil, potential complications from surgery such as infection or rejection of the transplant, and general risks associated with any ocular procedure.

DETECT I Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a previous cornea transplant that didn't work.

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I am willing and able to have a cornea transplant.

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I am older than 18 years.

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I have severe corneal swelling or guttata from Fuchs' dystrophy extending beyond the center.

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My glaucoma is managed with medication or surgery, and my eye pressure is stable.

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I have a specific type of corneal swelling or dysfunction.

DETECT I Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endothelial cell loss

Secondary outcome measures

Best spectacle-corrected visual acuity (BSCVA)

DETECT I Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: UT-DSAEK plus topical ripasudilExperimental Treatment1 Intervention

This arm will receive UT-DSAEK plus topical ripasudil 0.4%

Group II: DMEK plus topical ripasudilExperimental Treatment1 Intervention

This arm will receive DMEK plus topical ripasudil 0.4%

Group III: DMEK plus topical placeboPlacebo Group1 Intervention

This arm will receive DMEK plus topical placebo

Group IV: UT-DSAEK plus topical placeboPlacebo Group1 Intervention

This arm will receive UT-DSAEK plus topical placebo

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER

2,512 Previous Clinical Trials

15,244,299 Total Patients Enrolled

1 Trials studying Fuchs' Dystrophy

60 Patients Enrolled for Fuchs' Dystrophy

Stanford UniversityLead Sponsor

2,398 Previous Clinical Trials

17,341,485 Total Patients Enrolled

1 Trials studying Fuchs' Dystrophy

60 Patients Enrolled for Fuchs' Dystrophy

Oregon Health and Science UniversityOTHER

977 Previous Clinical Trials

7,386,161 Total Patients Enrolled

2 Trials studying Fuchs' Dystrophy

120 Patients Enrolled for Fuchs' Dystrophy

Media Library

Topical Ripasudil Clinical Trial Eligibility Overview. Trial Name: NCT05289661 — Phase 3

Fuchs' Dystrophy Research Study Groups: UT-DSAEK plus topical ripasudil, DMEK plus topical placebo, DMEK plus topical ripasudil, UT-DSAEK plus topical placebo

Fuchs' Dystrophy Clinical Trial 2023: Topical Ripasudil Highlights & Side Effects. Trial Name: NCT05289661 — Phase 3

Topical Ripasudil 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289661 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Topical Ripasudil have any dangerous side effects?

"Topical Ripasudil is believed to be safe according to our team's 3-point scale. This drug has undergone Phase 3 trials, which means that there is some data supporting its efficacy and multiple rounds of data supporting safety."

Answered by AI

Are we still enrolling new participants for this experiment?

"Yes, as of 8/23/2022, this clinical trial was still recruiting patients. The initial posting date for the study was 7/15/2022. Up to 160 people will be participate in the research at 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Descemet Endothelial Thickness Comparison Trial I

Jennifer Rose-Nussbaumer 2022. "Descemet Endothelial Thickness Comparison Trial I". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289661.