Trial | NCT03813056  Report issue

Title

Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in 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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Glanatec ...

  • Study Participants

    72
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.
Study Started
Mar 25
2019
Primary Completion
Feb 01
2023
Anticipated
Study Completion
Feb 01
2023
Anticipated
Last Update
Sep 05
2021

Drug Glanatec

Rho kinase Inhibitor

  • Other names: Ripasudil

Drug Optive, Ophthalmic Solution

artificial tears (placebo)

  • Other names: Optive, artificial tears

Procedure Descemet Membrane Endothelial Keratoplasty

Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.

  • Other names: DMEK

Glanatec Experimental

Glanatec eye drops will be administered 6x per day for 2-4 weeks

Placebo Control Placebo Comparator

Optive artificial tears will be administered 6x per day for 2-4 weeks

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.
No Results Posted