RecruitingPhase 4NCT03249337

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


Sponsor

Marian Macsai, MD

Enrollment

30 participants

Start Date

Dec 6, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 91 Years

Plain Language Summary

Simplified for easier understanding

This study tests Glanatec (ripasudil eye drops) as a treatment for Fuchs endothelial dystrophy — a condition where the cells lining the inside of the cornea progressively die, causing blurry vision. The treatment works by promoting new cell growth after the diseased layer is removed in a procedure called Descemet stripping. You may be eligible if: - You are between 30 and 91 years old - You have been diagnosed with Fuchs dystrophy grades 2–4 - Your cornea is clear on the edges with sufficient healthy cells - Your best corrected vision in the study eye is 20/40 or worse - You are otherwise a candidate for a corneal transplant - You have an intraocular lens (artificial lens) in the eye from prior cataract surgery You may NOT be eligible if: - You have uncontrolled glaucoma (eye pressure above 25 mmHg) - You have another corneal infection or autoimmune condition - You have advanced swelling of the cornea with haze or blisters - You have a history of herpes eye infection - You have previously had an endothelial corneal transplant in the study eye - You are pregnant or planning to become pregnant within 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRipasudil 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


Locations(1)

NorthShore University HealthSystem

Glenview, Illinois, United States

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NCT03249337


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