Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

Description

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal. The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.

Conditions

Fuchs Endothelial Dystrophy

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Study Overview

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Study Details

Study overview

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal. The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.

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

Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

Condition
Fuchs Endothelial Dystrophy
Intervention / Treatment

-

Contacts and Locations

Portland

Devers Eye Institute, Portland, Oregon, United States, 97210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

30 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Michael D. Straiko, MD,

Michael D Straiko, M.D., PRINCIPAL_INVESTIGATOR, Devers Eye Institute

Study Record Dates

2025-02-01