Using Ripasudil to Improve Corneal Healing After Eye Surgery for Fuchs' Dystrophy
A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy
This study is testing if a new eye drop called Ripasudil can help people with Fuchs' dystrophy heal better after eye surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 30 Years to 99 Years |
| Sex | All |
| Sponsor | Legacy Health System Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT03813056 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Ripasudil, a Rho kinase inhibitor, on corneal healing following Descemet Membrane Endothelial Keratoplasty (DMEK) in patients with Fuchs Endothelial Dystrophy. The research aims to determine if administering Ripasudil post-surgery can enhance endothelial cell recovery and expedite the clearing of corneal edema, potentially leading to fewer complications. Patients diagnosed with varying grades of Fuchs dystrophy will be treated with Ripasudil after their DMEK procedure to assess its efficacy. The study is designed to provide insights into improving surgical outcomes for this specific eye condition.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Fuchs endothelial corneal dystrophy who have specific visual acuity and corneal condition criteria.
Not a fit: Patients with uncontrolled glaucoma, advanced corneal pathology, or a history of certain viral keratitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve corneal clarity and reduce recovery time for patients undergoing DMEK surgery.
How similar studies have performed: Previous studies have shown promising results with Rho kinase inhibitors in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator. * Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens. * Fuchs dystrophy grades 2-5 on the Krachmer grading scale. * Presence of central guttae and/or stromal edema being the primary cause of decreased vision. * The peripheral cornea to the central 6mm is devoid of guttata changes. * Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment. Exclusion Criteria: * Uncontrolled glaucoma (IOP \>25 mmHg). * Presence of secondary corneal pathology such as infective or autoimmune keratitis. * Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy. * History of herpes simplex virus or cytomegalovirus keratitis. * Prior penetrating keratoplasty. * Aphakic in study eye. * Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study. * Tubes or trabeculectomy from prior glaucoma surgery.
Where this trial is running
Portland, Oregon
- Devers Eye Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Straiko, M.D. — Devers Eye Institute
- Study coordinator: Alex J Bauer, B.S.
- Email: alex@visiongift.org
- Phone: 503-413-8377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.