Clinical trial NCT03813056: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Fuchs Endothelial Dystrophy
Lead sponsor: Legacy Health System
Sponsor class: OTHER
Collaborators: name: Lions VisionGift Research
name: Eye Bank Association of America
First posted: 2019-01-23
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to corneal clearance
timeFrame: 6 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months
measure: Endothelial cell density
timeFrame: 6 months
measure: Post surgery complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
Study officials:
affiliation: Devers Eye Institute
name: Michael D Straiko, M.D.
role: PRINCIPAL_INVESTIGATOR
References: