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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for Fuchs' dystrophy, a condition that can cause cloudy vision due to issues with the inner layer of the cornea. Researchers aim to determine if using Ripasudil (an eye drop) with a procedure called Descemet Stripping Only (DSO) is as effective as the more common surgery, DMEK. Individuals diagnosed with Fuchs' dystrophy and experiencing clear vision problems related to it might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ripasudil is generally safe and well-tolerated for eye conditions. One study found that patients using Ripasudil eye drops after a procedure had healthier eye cells compared to those who did not use the drops, suggesting that Ripasudil may help protect the eye.

Another study focused on Ripasudil for Fuchs' Dystrophy and found that it can help clear the eye in some cases. It was deemed safe, with no major safety issues reported.

Overall, these studies suggest that Ripasudil is safe for treating certain eye conditions, though individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Ripasudil for Fuchs' Dystrophy because it offers a new approach compared to standard treatments like Descemet Membrane Endothelial Keratoplasty (DMEK). Ripasudil is a Rho kinase inhibitor, which works differently by enhancing the natural repair mechanisms of the corneal endothelium, potentially reducing the need for surgical intervention. This non-invasive, topical treatment could provide a more accessible and less risky option for patients, offering hope for improved vision with fewer complications.

What evidence suggests that this trial's treatments could be effective for Fuchs' dystrophy?

Research has shown that Ripasudil, an eye drop, may help treat Fuchs endothelial corneal dystrophy by making the cornea clearer. Studies have found these eye drops beneficial for early to moderate stages of the condition. In this trial, one group of participants will receive DSO plus topical Ripasudil 0.4%. Specifically, one study found that patients using Ripasudil lost fewer corneal cells compared to those who did not use it, suggesting that Ripasudil can protect the cornea and may aid in healing. Initial findings indicate it could be an advanced treatment for people with corneal endothelial issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Jennifer Rose-Nussbaumer, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8423139/

A Close Look at the Clinical Efficacy of Rho-Associated ... ROCK-inhibitor eye drops may eventually be deemed a cutting-edge therapy for Fuchs endothelial corneal dystrophy patients with acute corneal endothelial defect.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451993623000476

Twelve-year outcome of Rho-associated protein kinase ... The purpose of this case report is to present the long-term outcome of the treatment by ROCK inhibitor eye drops and trans-corneal freezing of damaged CECs.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03813056

Study Details | NCT03813056 | Ripasudil for Enhanced ... The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113375/

Rho-Kinase Inhibitors in the Management of Fuchs ... In general, clinical data indicate that these drugs can improve corneal clarity in early to moderate FECD, and they appear most effective when ...

5. aao.org aao.org/education/editors-choice/rock-inhibitor-may-help-protect-cornea-post-phaco-

A ROCK Inhibitor May Help Protect the Cornea Post-Phaco ... Three-month paracentral ECD loss was also lower in the ripasudil group (0.4%) than in the control group (7.3%), though this difference did not ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32740006/

Descemet Stripping Only Supplemented With Topical ... This trial of DSO supplemented with ripasudil included local and systemic safety analysis. We judge that this treatment option is emerging ...

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-ripasudil-eye-drops-for-patients-with-fuchs-endothelial-corneal-dystrophy-after-descemetorhexis/

Study on the Safety and Effectiveness of Ripasudil Eye ... This clinical trial investigates the safety and effectiveness of Ripasudil eye drops for improving vision in patients with Fuchs Endothelial Corneal ...

8. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2807041

Descemet Stripping Only combined with Ripasudil for treating ... Conclusions : DSO with ripasudil can restore corneal clarity in selected FECD cases, with a favorable safety profile. However, the success rate (6/14 eyes) was ...