Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

Sponsor

Massachusetts Eye and Ear Infirmary (Other)

Overall Status

Completed

CT.gov ID

NCT04057053

Collaborator

(none)

Enrollment

Location

Arms

26.6

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary aim of the study is to determine whether a rho kinase inhibitor, Netarsudil, can speed corneal clearance after DWEK. Secondary aim of the study is to investigate whether patient factors, such as baseline age, pachymetry, or endothelial cell count influence response to Netarsudil.

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Endothelial Dystrophy Cataract	Drug: Netarsudil 0.02% Ophthalmic Solution	Early Phase 1

Detailed Description

Spontaneous corneal clearance after Descemetorhexis without keratoplasty (DWEK) has been documented in several previous trials. One of the largest cohorts at Massachusetts Eye and Ear Infirmary demonstrated spontaneous corneal clearance in about 82% of cases but mean time to clearance was approximately three months after the procedure. During this time period, patients have significantly reduced central vision. Furthermore, some patients fail to have corneal clearance even eight months after DWEK and have to undergo Descemet membrane endothelial keratoplasty (DMEK) to achieve corneal clearance. A recent international case report has documents that the addition of a rho kinase inhibitor, Ripasudil, to two eyes that failed to clear by two to three months after DWEK resulted in corneal clearance within two weeks after the addition of Ripasudil. This finding indicates the possibility that a rho kinase inhibitor can be used to speed corneal clearance after purposeful Descemetorhexis. The only FDA approved rho kinase inhibitor eye drop currently available is Netarsudil, approved in December of 2017 for use in ocular hypertension and primary open angle glaucoma. Investigating whether Netarsudil can speed corneal clearance after DWEK is truly importance as the potential to expand patient eligibility for DWEK is significant. Both patients that had previously not wanted to wait approximately three months after the procedure for corneal clearance as well as patients with lower mid-peripheral endothelial cell counts may now be eligible for a procedure to treat corneal endothelial dysfunction without a corneal transplant. This would reduce risks for corneal transplant rejection and failure, reduce need for long-term steroid eye drop use, and reduce need for frequent corneal screenings to ensure transplant health.

The current study aims to investigate whether the off-label use of Netarsudil can improve corneal clearance after DWEK in Fuchs endothelial dystrophy patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This is a pilot study to determine whether there is any benefit to using Netarsudil after DWEK surgery. The study plans to enroll 10 patients (20 eyes) with Fuchs endothelial dystrophy and cataract to under combined cataract surgery with DWEK sequentially in both eyes. The first eye will be treated with Netarsudil after surgery and time to clearance will be noted. The second eye will not be treated with Netarsudil and if time to clearance is longer than the first eye, Netarsudil will be added to test if it can be used as a "rescue" drop.This is a pilot study to determine whether there is any benefit to using Netarsudil after DWEK surgery. The study plans to enroll 10 patients (20 eyes) with Fuchs endothelial dystrophy and cataract to under combined cataract surgery with DWEK sequentially in both eyes. The first eye will be treated with Netarsudil after surgery and time to clearance will be noted. The second eye will not be treated with Netarsudil and if time to clearance is longer than the first eye, Netarsudil will be added to test if it can be used as a "rescue" drop.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

Actual Study Start Date :

Oct 2, 2018

Actual Primary Completion Date :

Dec 20, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Netarsudil use Patient eye undergoes cataract surgery + DWEK, immediately after surgery Netarsudil 0.02% ophthalmic 1 drop daily is used in the operative eye until corneal clearance is documented.	Drug: Netarsudil 0.02% Ophthalmic Solution Use of Netarsudil 0.02% ophthalmic solution daily after surgery
Active Comparator: Standard of care + possible rescue drop Patient eye undergoes cataract surgery + DWEK, no Netarsudil is used after surgery, if cornea is not cleared in time for first eye Netarsudil 0.02% ophthalmic 1 drop dailyadded daily as possible rescue drop and time to corneal clearance is documented	Drug: Netarsudil 0.02% Ophthalmic Solution Use of Netarsudil 0.02% ophthalmic solution daily after surgery

Arm

Intervention/Treatment

Experimental: Netarsudil use

Patient eye undergoes cataract surgery + DWEK, immediately after surgery Netarsudil 0.02% ophthalmic 1 drop daily is used in the operative eye until corneal clearance is documented.

Drug: Netarsudil 0.02% Ophthalmic Solution

Use of Netarsudil 0.02% ophthalmic solution daily after surgery

Active Comparator: Standard of care + possible rescue drop

Patient eye undergoes cataract surgery + DWEK, no Netarsudil is used after surgery, if cornea is not cleared in time for first eye Netarsudil 0.02% ophthalmic 1 drop dailyadded daily as possible rescue drop and time to corneal clearance is documented

Drug: Netarsudil 0.02% Ophthalmic Solution

Use of Netarsudil 0.02% ophthalmic solution daily after surgery

Outcome Measures

Primary Outcome Measures

Time to corneal clearance [Through study completion, an average of 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cataract in both eyes
Fuchs endothelial dystrophy in both eyes

Exclusion Criteria:

History of ocular surgery in one eye and not the other
History of significant ocular trauma/burn in one eye and not the other
Inability to provide informed consent
Inability to undergo eye surgery
Inablity to use eye drops reliably

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

Investigators

Principal Investigator: Emma E Davies, Massachusetts Eye and Ear Infirmary
Principal Investigator: Roberto Pineda, Massachusetts Eye and Ear Infirmary
Principal Investigator: Ula Jurkunas, Massachusetss Eye and Ear Infirmary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Emma C. Davies, MD, Assistant Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary

ClinicalTrials.gov Identifier:

NCT04057053

Other Study ID Numbers:

18-101H
2019P000908

First Posted:

Aug 14, 2019

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Emma C. Davies, MD, Assistant Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary

DWEK, Netarsudil

Additional relevant MeSH terms:

Cataract

Fuchs' Endothelial Dystrophy

Ophthalmic Solutions

Study Results

No Results Posted as of Jan 26, 2021