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

August 9, 2021 updated by: Marian Macsai, MD

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northshore University HealthSystem
        • Contact:
        • Principal Investigator:
          • Marian Macsai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glanatec(R) 3 times a day
the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
Other Names:
  • Glanatec
Active Comparator: Glanatec (R) 6 times a day
the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
Other Names:
  • Glanatec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal Clearing
Time Frame: 12 months
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
pachymetry measurement
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 10, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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