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

Primary Purpose

Fuchs Endothelial Dystrophy

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glanatec
Optive, Ophthalmic Solution
Descemet Membrane Endothelial Keratoplasty
Sponsored by
Michael D. Straiko, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs Endothelial Dystrophy

Eligibility Criteria

30 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Devers Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glanatec

Placebo Control

Arm Description

Glanatec eye drops will be administered 6x per day for 2-4 weeks

Optive artificial tears will be administered 6x per day for 2-4 weeks

Outcomes

Primary Outcome Measures

Time to corneal clearance
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.

Secondary Outcome Measures

Best corrected visual acuity
Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
Endothelial cell density
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
Post surgery complications
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.

Full Information

First Posted
January 19, 2019
Last Updated
September 2, 2021
Sponsor
Michael D. Straiko, MD
Collaborators
Lions VisionGift Research, Eye Bank Association of America
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1. Study Identification

Unique Protocol Identification Number
NCT03813056
Brief Title
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael D. Straiko, MD
Collaborators
Lions VisionGift Research, Eye Bank Association of America

4. Oversight

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

5. Study Description

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.

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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glanatec
Arm Type
Experimental
Arm Description
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Arm Description
Optive artificial tears will be administered 6x per day for 2-4 weeks
Intervention Type
Drug
Intervention Name(s)
Glanatec
Other Intervention Name(s)
Ripasudil
Intervention Description
Rho kinase Inhibitor
Intervention Type
Drug
Intervention Name(s)
Optive, Ophthalmic Solution
Other Intervention Name(s)
Optive, artificial tears
Intervention Description
artificial tears (placebo)
Intervention Type
Procedure
Intervention Name(s)
Descemet Membrane Endothelial Keratoplasty
Other Intervention Name(s)
DMEK
Intervention Description
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Primary Outcome Measure Information:
Title
Time to corneal clearance
Description
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
Time Frame
6 months
Title
Endothelial cell density
Description
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
Time Frame
6 months
Title
Post surgery complications
Description
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex J Bauer, B.S.
Phone
503-413-8377
Email
alex@visiongift.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael D Straiko, M.D.
Phone
503-413-8032
Email
mike.straiko@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Straiko, M.D.
Organizational Affiliation
Devers Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex J Bauer, B.S.
Phone
503-413-8377
Email
alex@visiongift.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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