RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2017-12-06
Study Completion:2021-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03249337

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.

Ages Eligible for Study:18 Years to 91 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Ability to understand read and sign the informed consent form.
  2. * Age between 30 and \<91 years
  3. * Ability to understand and follow instructions and study procedures
  4. * Willingness to comply with all study procedures and be available for the duration of the study
  5. * Ability to apply eye drop medication and willing to adhere to study medication regimen
  6. * Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
  7. * Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
  8. * Fuchs dystrophy grades 2-4 on the Krachmer grading scale
  9. * Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
  10. * Clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy
  11. * Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
  12. * The patient is dissatisfied with current vision
  13. * The patient is otherwise to be offered a corneal graft
  14. * For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
  15. * Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
  1. * • Uncontrolled glaucoma (IOP \>25 mmHg)
  2. * Presence of secondary corneal pathology such as infective or autoimmune keratitis
  3. * Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
  4. * History of herpes simplex virus or cytomegalovirus keratitis
  5. * Prior endothelial keratoplasty
  6. * Aphakic in study eye.
  7. * Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
  8. * For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
  9. * Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.

Contacts and Locations

Study Contact

Duanny Alva, MPH
CONTACT
847-570-1783
dalva@northshore.org
Marian Macsai, MD
CONTACT
847-657-1936
mmacsai@northshore.org

Study Locations (Sites)

NorthShore University HealthSystem
Glenview, Illinois, 60026
United States

Collaborators and Investigators

Sponsor: Marian Macsai, MD

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 Registration Dates

Study Start Date2017-12-06
Study Completion Date2021-12

Study Record Updates

Study Start Date2017-12-06
Study Completion Date2021-12

Terms related to this study

Additional Relevant MeSH Terms

  • Fuchs' Endothelial Dystrophy