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

Fuchs Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03813056
• Other study ID #: RDMEK-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2019
• Est. completion date: February 1, 2025

Study information

• Verified date: March 2024
• Source: Legacy Health System
• Contact: Alex J Bauer, B.S.
• Phone: 503-413-8377
• Email: alex[@]visiongift.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fuchs Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Glanatec
Rho kinase Inhibitor
• Optive, Ophthalmic Solution
artificial tears (placebo)

Procedure:
• Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.

Locations

Country	Name	City	State
United States	Devers Eye Institute	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Michael D. Straiko, MD	Eye Bank Association of America, Lions VisionGift Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to corneal clearance	Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.	6 months
Secondary	Best corrected visual acuity	Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.	6 months
Secondary	Endothelial cell density	Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.	6 months
Secondary	Post surgery complications	Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.	6 months