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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04057053
Other study ID # 18-101H
Secondary ID 2019P000908
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 2, 2018
Est. completion date December 20, 2020

Study information

Verified date January 2021
Source Massachusetts Eye and Ear Infirmary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 20, 2020
Est. primary completion date December 20, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Netarsudil 0.02% Ophthalmic Solution
Use of Netarsudil 0.02% ophthalmic solution daily after surgery

Locations

Country Name City State
United States Massachusetts Eye and Ear Infirmary Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to corneal clearance Through study completion, an average of 6 months
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