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Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty

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ClinicalTrials.gov Identifier: NCT04057053
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Emma C. Davies, MD, Massachusetts Eye and Ear Infirmary

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Netarsudil Use After Descemetorhexis Without Endothelial Keratoplasty
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Netarsudil

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




Primary Outcome Measures :
  1. Time to corneal clearance [ Time Frame: Through study completion, an average of 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057053


Contacts
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Contact: Emma E Davies 6102992673 ext 6102992673 emma_davies@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emma Davies, MD    610-299-2673    emma_davies@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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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

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Responsible Party: Emma C. Davies, MD, Assistant Professor of Ophthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT04057053     History of Changes
Other Study ID Numbers: 18-101H
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Emma C. Davies, MD, Massachusetts Eye and Ear Infirmary:
DWEK, Netarsudil
Additional relevant MeSH terms:
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Cataract
Fuchs' Endothelial Dystrophy
Lens Diseases
Eye Diseases
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Ophthalmic Solutions
Pharmaceutical Solutions