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Rho Kinase Inhibitor

DMEK vs. DSO + Ripasudil for Fuchs' Dystrophy (DETECT II 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 FECD with few guttata extending beyond 4.5 mm
Willingness and ability to undergo corneal transplantation
Must not have
Any prior intraocular surgery other than cataract surgery
Hypotony (Intraocular pressure <10mmHg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 24 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing two different treatments for Fuchs endothelial dystrophy, a disease of the eye. One treatment is Descemet Membrane Endothelial Keratoplasty (DMEK), while the other is Descemet Stripping Only (DSO) with adjunctive Ripasudil. 60 patients will be randomly assigned to one of these two treatments to see which is more effective.

Who is the study for?
This trial is for adults over 18 with Fuchs' Dystrophy, a specific eye condition. Participants must have certain characteristics of the disease, be good candidates for corneal surgery, and willing to use study medications and attend follow-up visits. Those with other eye conditions or recent surgeries, poor vision in the other eye, pregnancy, or inability to follow post-op instructions are excluded.
What is being tested?
The DETECT II trial is testing whether adding Ripasudil (a drug) to Descemet Stripping Only (DSO) procedure improves outcomes compared to the standard corneal transplant technique called DMEK. Patients will either receive this new combination or a placebo alongside their surgical treatment.
What are the potential side effects?
While specific side effects of Ripasudil aren't listed here, common ones may include mild irritation in the eyes such as burning sensation or redness. Since it's used adjunctively with surgery, typical surgical risks like infection also apply.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye condition affects the inner layer of my cornea and has spread beyond 4.5 mm.
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I am willing and able to have a cornea transplant.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had eye surgery, but it was not for cataracts.
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My eye pressure is lower than normal.
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My study eye has or will have a special lens due to missing natural lens.
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I have a condition affecting the inner lining of my blood vessels.
Select...
I can follow post-surgery care instructions.
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I have a serious eye condition affecting my optic nerve or macula.
Select...
I have blood vessels growing in more than one area of my cornea.
Select...
My eye has iris adhesion to the angle in more than 3 clock hours.
Select...
My other eye's vision is worse than 20/200.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Best spectacle-corrected visual acuity (BSCVA)
Endothelial cell density

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DSO plus topical ripasudil 0.4%Experimental Treatment1 Intervention
Group II: DMEK plus topical placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ripasudil
2022
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,586 Previous Clinical Trials
14,900,004 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,758 Total Patients Enrolled
Case Western Reserve UniversityOTHER
308 Previous Clinical Trials
250,653 Total Patients Enrolled

Media Library

Ripasudil (Rho Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05275972 — Phase 3
Fuchs' Dystrophy Research Study Groups: DSO plus topical ripasudil 0.4%, DMEK plus topical placebo
Fuchs' Dystrophy Clinical Trial 2023: Ripasudil Highlights & Side Effects. Trial Name: NCT05275972 — Phase 3
Ripasudil (Rho Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05275972 — Phase 3
~31 spots leftby Nov 2026
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