Ripasudil for Enhanced Corneal Clearing Following Desceme... | NCT03813056

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2019Actual

Primary Completion Date

Feb 1, 2025Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Jan 19, 2019

First Submission Date that Met QC Criteria

Jan 19, 2019

First Posted Date

Jan 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Name	Class
Lions VisionGift Research	OTHER
Eye Bank Association of America	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Glanatec	Drug	Rho kinase Inhibitor	Glanatec	Ripasudil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Best corrected visual acuity	Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.	6 months
Endothelial cell density

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Michael D Straiko, M.D.	Devers Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Devers Eye Institute	Recruiting	Portland	Oregon	97210	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003317	Corneal Dystrophies, Hereditary
D003316	Corneal Diseases
D005128	Eye Diseases
D015785	Eye Diseases, Hereditary
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
C584679	K-115
D009883	Ophthalmic Solutions
D065346	Lubricant Eye Drops

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D020313	Specialty Uses of Chemicals
D054327	Lubricants