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

Michael D. Straiko, MD

Status and phase: Enrolling; Phase 2

Conditions: Fuchs Endothelial Dystrophy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03813056

RDMEK-01

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 30 to 99 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Glanatec

Experimental group

Description:

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

Treatment:

Drug: Glanatec

Procedure: Descemet Membrane Endothelial Keratoplasty

Placebo Control

Placebo Comparator group

Description:

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

Treatment:

Drug: Optive, Ophthalmic Solution

Procedure: Descemet Membrane Endothelial Keratoplasty