DMEK vs. DSO + Ripasudil for Fuchs' Dystrophy

(DETECT II Trial)

Recruiting at 6 trial locations

Overseen By Maalika Kanchugantla, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Must be taking: Ripasudil

Disqualifiers: Aphakia, Optic nerve pathology, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Jennifer Rose-Nussbaumer, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

My eye condition affects the inner layer of my cornea and has spread beyond 4.5 mm.

I am willing and able to have a cornea transplant.

I am willing to take the study medications as directed.

Exclusion Criteria

Pregnancy

I had cataract surgery in the last 3 months.

I have had eye surgery, but it was not for cataracts.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either DMEK or Descemet Stripping Only (DSO) with adjunctive Ripasudil

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Assessments at 3, 6, and 24 months

Treatment Details

Interventions

• Placebo
• Ripasudil

Trial Overview 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.

Participant Groups

Group I: DSO plus topical ripasudil 0.4% Experimental Treatment 1 Intervention

Group II: DMEK plus topical placebo Placebo Group 1 Intervention

Ripasudil is already approved in Japan for the following indications:

Approved in Japan as Glanatec for:

• Glaucoma
• Ocular hypertension

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Wills Eye Hospital

Collaborator

Trials

3

Recruited

230+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+