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

Trial Summary

What is the purpose of this trial?

This trial is evaluating different corneal transplant methods and a medication to see which approach improves vision and helps protect eye cells.

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.

Research Team

Jennifer Rose-Nussbaumer, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+