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

NCT03249337 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: EH17-320
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Visual Acuity

  12 months

Study Arms (2)

Glanatec(R) 3 times a day

ACTIVE COMPARATOR

Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

Glanatec (R) 6 times a day

ACTIVE COMPARATOR

Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

Interventions

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

Also known as: Glanatec

Glanatec (R) 6 times a day; Glanatec(R) 3 times a day

Eligibility Criteria

• Age: 18 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marian Macsai, MD: lead

Study Sites (1)

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

Ophthalmic Solutions; K-115

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Central Study Contacts

Duanny Alva, MPH

CONTACT

847-570-1783; dalva@northshore.org

Marian Macsai, MD

CONTACT

847-657-1936; mmacsai@northshore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Ophthalmology

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: December 6, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)