- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03249337
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Duanny Alva, MPH
- Phone Number: 847-570-1783
- Email: DAlva@northshore.org
Study Contact Backup
- Name: Marian Macsai, MD
- Phone Number: 847-657-1936
- Email: mmacsai@northshore.org
Study Locations
-
-
Illinois
-
Glenview, Illinois, United States, 60026
- Recruiting
- Northshore University HealthSystem
-
Contact:
- Duanny Alva, MPH
- Phone Number: 847-570-1783
- Email: dalva@northore.org
-
Principal Investigator:
- Marian Macsai, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH17-320
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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