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

Fuchs' Endothelial Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03249337
• Other study ID #: EH17-320
• Status: Recruiting
• Phase: Phase 4
• Start date: December 6, 2017
• Est. completion date: December 2021

Study information

• Verified date: August 2021
• Source: NorthShore University HealthSystem
• Contact: Duanny Alva, MPH
• Phone: 847-570-1783
• Email: dalva[@]northshore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 91 Years

Eligibility

Inclusion Criteria:

• • Ability to understand read and sign the informed consent form.

• Age between 30 and <91 years

• Ability to understand and follow instructions and study procedures

• Willingness to comply with all study procedures and be available for the duration of the study

• Ability to apply eye drop medication and willing to adhere to study medication regimen

• Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.

• Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.

• Fuchs dystrophy grades 2-4 on the Krachmer grading scale

• Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema

• Clear peripheral cornea with an endothelial cell count >1000 cells/mm2 on specular microscopy

• Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment

• The patient is dissatisfied with current vision

• The patient is otherwise to be offered a corneal graft

• For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).

• Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation

Exclusion Criteria:

• • Uncontrolled glaucoma (IOP >25 mmHg)

• Presence of secondary corneal pathology such as infective or autoimmune keratitis

• Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy

• History of herpes simplex virus or cytomegalovirus keratitis

• Prior endothelial 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

• For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.

• Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.

Related Conditions & MeSH terms

• Fuchs' Endothelial Dystrophy

Intervention

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

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Glenview	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Marian Macsai, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Clearing	The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping	12 months
Primary	pachymetry measurement	The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.	12 months
Secondary	Visual Acuity	The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.	12 months