Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 30 - 99 |
| Updated: | 3/2/2019 |
| Start Date: | March 1, 2019 |
| End Date: | February 1, 2020 |
| Contact: | Alex J Bauer, B.S. |
| Email: | alex@visiongift.org |
| Phone: | 503-413-8377 |
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
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.
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.
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.
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