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

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
Sponsored by
Marian Macsai, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy

Eligibility Criteria

18 Years - 91 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NorthShore University HealthSystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glanatec(R) 3 times a day

Glanatec (R) 6 times a day

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 10, 2017
Last Updated
August 9, 2021
Sponsor
Marian Macsai, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03249337
Brief Title
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marian Macsai, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glanatec(R) 3 times a day
Arm Type
Active Comparator
Arm Title
Glanatec (R) 6 times a day
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
Other Intervention Name(s)
Glanatec
Intervention Description
the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
Primary Outcome Measure Information:
Title
Corneal Clearing
Description
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
Time Frame
12 months
Title
pachymetry measurement
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
91 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duanny Alva, MPH
Phone
847-570-1783
Email
dalva@northshore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Macsai, MD
Phone
847-657-1936
Email
mmacsai@northshore.org
Facility Information:
Facility Name
NorthShore University HealthSystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duanny Alva, MPH
Phone
847-570-1783
Email
dalva@northore.org
First Name & Middle Initial & Last Name & Degree
Marian Macsai, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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