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

March 19, 2024 updated by: Michael D. Straiko, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Devers Eye Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glanatec
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Drug: Glanatec
Rho kinase Inhibitor
Other Names:
  • Ripasudil
Procedure: Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Other Names:
  • DMEK
Placebo Comparator: Placebo Control
Optive artificial tears will be administered 6x per day for 2-4 weeks
Procedure: Descemet Membrane Endothelial Keratoplasty
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Other Names:
  • DMEK
Drug: Optive, Ophthalmic Solution
artificial tears (placebo)
Other Names:
  • Optive, artificial tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Endothelial cell density
Time Frame: 6 months
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
6 months
Post surgery complications
Time Frame: 6 months
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael D. Straiko, MD

Collaborators

Lions VisionGift Research
Eye Bank Association of America

Investigators

  • Principal Investigator: Michael D Straiko, M.D., Devers Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 19, 2019

First Submitted That Met QC Criteria

January 19, 2019

First Posted (Actual)

January 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDMEK-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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