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Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

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ClinicalTrials.gov Identifier: NCT03813056
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Lions VisionGift Research
Eye Bank Association of America
Information provided by (Responsible Party):
Michael D. Straiko, MD, Legacy Health System

Brief Summary:

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.

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.


Condition or disease Intervention/treatment Phase
Fuchs Endothelial Dystrophy Drug: Glanatec Drug: Optive, Ophthalmic Solution Procedure: Descemet Membrane Endothelial Keratoplasty Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glanatec
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Drug: Glanatec
Rho kinase Inhibitor
Other Name: Ripasudil

Procedure: Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Other Name: DMEK

Placebo Comparator: Placebo Control
Optive artificial tears will be administered 6x per day for 2-4 weeks
Drug: Optive, Ophthalmic Solution
artificial tears (placebo)
Other Name: Optive, artificial tears

Procedure: Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Other Name: DMEK




Primary Outcome Measures :
  1. Time to corneal clearance [ Time Frame: 6 months ]
    Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 6 months ]
    Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.

  2. Endothelial cell density [ Time Frame: 6 months ]
    Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.

  3. Post surgery complications [ Time Frame: 6 months ]
    Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.



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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
  • 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:

  • Uncontrolled glaucoma (IOP >25 mmHg).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813056


Contacts
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Contact: Alex J Bauer, B.S. 503-413-8377 alex@visiongift.org
Contact: Michael D Straiko, M.D. 503-413-8032 mike.straiko@gmail.com

Locations
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United States, Oregon
Devers Eye Institute Recruiting
Portland, Oregon, United States, 97210
Contact: Alex J Bauer, B.S.    503-413-8377    alex@visiongift.org   
Sponsors and Collaborators
Michael D. Straiko, MD
Lions VisionGift Research
Eye Bank Association of America
Investigators
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Principal Investigator: Michael D Straiko, M.D. Legacy Devers Eye Institute

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Responsible Party: Michael D. Straiko, MD, Associate Director of Corneal Services, Devers Eye Institute, Legacy Health System
ClinicalTrials.gov Identifier: NCT03813056     History of Changes
Other Study ID Numbers: RDMEK-01
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions