NCT03813056

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Michael D. Straiko, MD · Academic / Other
• Sex: All
• Age: 30 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fuchs Endothelial Dystrophy

Interventions

Type	Name	Description
DRUG	Glanatec	Rho kinase Inhibitor
DRUG	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.

Timeline

• Start date: 2019-03-25
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2019-01-23
• Last updated: 2024-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study