Ripasudil for Fuchs' Dystrophy

(DETECT I Trial)

Recruiting at 6 trial locations

Overseen By Maalika Kanchugantla, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Disqualifiers: Aphakia, Pregnancy, Optic nerve, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for individuals with Fuchs’ Dystrophy, a condition affecting the eye's clear front layer and causing vision problems. It compares two types of corneal transplant surgeries to determine which improves vision more effectively. Additionally, the trial tests whether Ripasudil, administered as a topical treatment, can protect eye cells after surgery. Suitable candidates for this trial include those diagnosed with Fuchs’ Dystrophy or similar conditions who experience significant vision issues due to problems with the cornea's inner layer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatments for vision improvement.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants with controlled glaucoma can continue using topical medications, so you might be able to stay on some medications.

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

Research has shown that ripasudil, a medication used in eye treatments, is generally safe. Studies have found that ripasudil in eye drops does not cause major side effects. In trials with patients who have Fuchs endothelial corneal dystrophy, no serious problems were linked to ripasudil. Some individuals experienced minor side effects, such as mild eye irritation, but these are uncommon. This suggests that ripasudil is a safe option for treating eye conditions. However, consulting a healthcare provider for personal advice is always recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Ripasudil for Fuchs' Dystrophy because it introduces a unique mechanism of action compared to current standard treatments like corneal transplantation. Ripasudil is a Rho kinase inhibitor, which helps to reduce corneal edema and improve endothelial cell function, aiming to restore vision by enhancing the eye's natural repair processes. Unlike traditional surgical approaches, Ripasudil is administered topically as eye drops, potentially offering a non-invasive treatment option with fewer risks and recovery time. This could represent a significant advancement in managing Fuchs' Dystrophy, offering patients a simpler, less daunting treatment path.

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

Research has shown that ripasudil, a type of medication, can protect the cornea and reduce cell loss after corneal surgeries. In this trial, some participants will undergo DMEK or UT-DSAEK surgery combined with topical ripasudil. One study found that patients using ripasudil experienced significantly less loss of important corneal cells compared to those who did not. Another study discovered a 9% increase in these cells among patients using ripasudil, while those on a placebo did not experience this improvement. These findings suggest that ripasudil effectively maintains corneal health and aids recovery after surgeries like DMEK and UT-DSAEK. ^{1 4 5 6 7}

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 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.

Inclusion Criteria

I am willing to attend all follow-up appointments.

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

I am willing and able to have a cornea transplant.

Exclusion Criteria

My other eye's vision is worse than 20/200.

I had cataract surgery in the last 3 months.

My eye has iris adhesion to the angle in more than 3 clock hours.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo corneal transplant surgeries (UT-DSAEK or DMEK) and receive either topical ripasudil or placebo

12 months

Follow-up

Participants are monitored for endothelial cell loss and visual acuity

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Topical Placebo
• Topical Ripasudil

Trial Overview 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.

How Is the Trial Designed?

Group I: UT-DSAEK plus topical ripasudil Experimental Treatment 1 Intervention

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

Group II: DMEK plus topical ripasudil Experimental Treatment 1 Intervention

This arm will receive DMEK plus topical ripasudil 0.4%

Group III: DMEK plus topical placebo Placebo Group 1 Intervention

This arm will receive DMEK plus topical placebo

Group IV: UT-DSAEK plus topical placebo Placebo Group 1 Intervention

This arm will receive UT-DSAEK plus topical placebo

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+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Wills Eye Hospital

Collaborator

Trials

3

Recruited

230+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dartmouth-Hitchcock Medical Center

Collaborator

Trials

548

Recruited

2,545,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39946654/

Efficacy of the Rho-Kinase Inhibitor for Corneal Endothelial ... Results: There was significantly less cell loss among those eyes treated with ripasudil. C-ECD significantly increased from a baseline of 2361 ...

2. 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 ...

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

Twelve-year outcome of Rho-associated protein kinase ... At 2 years post treatment, the cornea remained clear with good (20/16) visual acuity (VA) (C). No corneal edema was observed, and the CCT was 587 μm (D). At 12 ...

4. 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 months after surgery, significant differences were seen in C-ECD, with the ripasudil group improving by 9.0% while the placebo group ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12347265/

Clinical Evaluation of Ripasudil for Corneal Edema This study demonstrates the variable therapeutic efficacy of Ripasudil across different causes of corneal edema, with greatest therapeutic gains ...

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. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02169390&doi=10.1002/central/CN-02169390&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

A Study to Investigate the Safety and Efficacy of Ripasudil ... A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Patients with Fuchs Endothelial Corneal Dystrophy.