NCT03249337

Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy

A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Marian Macsai, MD · Academic / Other
• Sex: All
• Age: 18 Years – 91 Years
• Healthy volunteers: Not accepted

Summary

In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety. The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.

Conditions

• Fuchs' Endothelial Dystrophy

Interventions

Type	Name	Description
DRUG	Ripasudil hydrochloride hydrate 0.4% ophthalmic solution	the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment

Timeline

• Start date: 2017-12-06
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-08-15
• Last updated: 2021-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study