Recruiting
Phase 2

DMEK with Ripasudil

Sponsor:

Michael D. Straiko, MD

Code:

NCT03813056

Conditions

Fuchs Endothelial Dystrophy

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Glanatec

Optive, Ophthalmic Solution

Descemet Membrane Endothelial Keratoplasty

Study Details

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

Study ID

NCT03813056

Start date

Mar 25, 2019

Status verified date

Mar, 2024

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Glanatec

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

placebo comparator: Placebo Control

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

Interventions

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.

Primary outcome measure

  • Time to corneal clearance [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Alex J Bauer, B.S.

503-413-8377alex@visiongift.org

Michael D Straiko, M.D.

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

Locations

Devers Eye Institute

Recruiting

Portland, Oregon, United States, 97210

Contacts

Alex J Bauer, B.S.

503-413-8377alex@visiongift.org

More Information

Sponsor

Michael D. Straiko, MD

Last update posted

Mar 20, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michael D. Straiko, MD on 2024-03-20.