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NCT Number: NCT03249337

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

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.

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Key information

Conditions

Fuchs' Endothelial Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn

Age range

18 year–91 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location status: Recruiting

Location contact

Duanny Alva, MPH

CONTACT

[email protected]

847-570-1783

Marian Macsai, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

Drug

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Duanny Alva, MPH

CONTACT

[email protected]

847-570-1783

Marian Macsai, MD

CONTACT

[email protected]

847-657-1936

Sponsors and collaborators

Lead sponsor

Marian Macsai, MD

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2017
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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