Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
NCT ID: NCT03813056
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
72 participants
INTERVENTIONAL
2019-03-25
2025-02-01
Brief Summary
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Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.
The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Glanatec
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Glanatec
Rho kinase Inhibitor
Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Placebo Control
Optive artificial tears will be administered 6x per day for 2-4 weeks
Optive, Ophthalmic Solution
artificial tears (placebo)
Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Interventions
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Glanatec
Rho kinase Inhibitor
Optive, Ophthalmic Solution
artificial tears (placebo)
Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
* Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
* Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
* The peripheral cornea to the central 6mm is devoid of guttata changes.
* Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.
Exclusion Criteria
* Presence of secondary corneal pathology such as infective or autoimmune keratitis.
* Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
* History of herpes simplex virus or cytomegalovirus keratitis.
* Prior penetrating 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.
* Tubes or trabeculectomy from prior glaucoma surgery.
30 Years
99 Years
ALL
No
Sponsors
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Lions VisionGift Research
OTHER
Eye Bank Association of America
OTHER
Michael D. Straiko, MD
OTHER
Responsible Party
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Michael D. Straiko, MD
Associate Director of Corneal Services, Devers Eye Institute
Principal Investigators
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Michael D Straiko, M.D.
Role: PRINCIPAL_INVESTIGATOR
Devers Eye Institute
Locations
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Devers Eye Institute
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RDMEK-01
Identifier Type: -
Identifier Source: org_study_id
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