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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 24 months
Awards & highlights

DETECT II 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.Check my eligibility
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.See study design
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.

DETECT II Trial 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.
Select...
I am willing and able to have a cornea transplant.
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I am older than 18 years.

DETECT II Trial 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

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

DETECT II 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
2,496 Previous Clinical Trials
11,933,429 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,034 Total Patients Enrolled
University of California, DavisOTHER
909 Previous Clinical Trials
4,704,070 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

Frequently Asked Questions

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

Is this trial also being conducted in other parts of Canada?

"The 4th and final location for this trial is still being decided, but the other three sites are at University of California Davis in Sacramento, Oregon Health & Science University in Portland, and Stanford University in Palo Alto."

Answered by AI

What is the hard cap for patient recruitment in this experiment?

"That is correct. The clinicaltrials.gov website has information indicating that the trial is still recruiting patients. The trial was posted on 7/15/2022 and was updated on 8/23/2022. The study is seeking 60 participants from 4 locations."

Answered by AI

Is this research project still looking for participants?

"This trial is currently recruiting participants, as noted on clinicaltrials.gov. The listing was originally posted on July 15, 2022, and last updated on August 23, 2022."

Answered by AI

Are there any documented cases of serious harm caused by Ripasudil?

"There is some evidence of efficacy and numerous reports of Ripasudil's safety, so it was given a score of 3."

Answered by AI
~40 spots leftby Nov 2026