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

NCT03813056 | Recruiting Phase 2 FDA Drug

• 1 other identifier: RDMEK-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

• Time to corneal clearance

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

  6 months

Secondary Outcomes (3)

• Best corrected visual acuity

  6 months

• Endothelial cell density

  6 months

• Post surgery complications

  6 months

Study Arms (2)

Glanatec

EXPERIMENTAL

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

Drug: Glanatec; Procedure: Descemet Membrane Endothelial Keratoplasty

Placebo Control

PLACEBO COMPARATOR

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

Drug: Optive, Ophthalmic Solution; Procedure: Descemet Membrane Endothelial Keratoplasty

Interventions

Glanatec DRUG

Rho kinase Inhibitor

Also known as: Ripasudil

Glanatec

Optive, Ophthalmic Solution DRUG

artificial tears (placebo)

Also known as: Optive, artificial tears

Placebo Control

Descemet Membrane Endothelial Keratoplasty PROCEDURE

Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.

Also known as: DMEK

Glanatec; Placebo Control

Eligibility Criteria

• Age: 30 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael D. Straiko, MD: lead
• Lions VisionGift Research: collaborator
• Eye Bank Association of America: collaborator

Study Sites (1)

Devers Eye Institute

Portland, Oregon, 97210, United States

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

K-115; Ophthalmic Solutions; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Lubricants

Study Officials

• Michael D Straiko, M.D.

  Devers Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex J Bauer, B.S.

CONTACT

503-413-8377; alex@visiongift.org

Michael D Straiko, M.D.

CONTACT

503-413-8032; mike.straiko@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director of Corneal Services, Devers Eye Institute

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 23, 2019
• Study Start: March 25, 2019
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)