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Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

Primary Purpose

Fuchs' Endothelial Dystrophy

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Netarsudil Ophthalmic
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Dystrophy focused on measuring Descemetorhexis without endothelial keratoplasty

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fuchs corneal dystrophy

Exclusion Criteria:

  • Women of childbearing potential
  • Other corneal eye diseases
  • Non-compliance with netarsudil
  • Intolerance of netarsudil

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Netarsudil use

Arm Description

Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance

Outcomes

Primary Outcome Measures

Change in central corneal pachymetry over time
Corneal thickness on clinical examination and corneal topography
Change in endothelial cell count over time
Central endothelial cell count by specular microscopy

Secondary Outcome Measures

Full Information

First Posted
February 2, 2021
Last Updated
October 17, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT04752020
Brief Title
Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty
Official Title
Prospective Assessment of Whether Adjuvant Netarsurdil Use Improves Post-Operative Outcomes in Patients Undergoing Descemetorhexis Without Endothelial Keratoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 28, 2021 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.
Detailed Description
Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart. Upon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes. A retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy
Keywords
Descemetorhexis without endothelial keratoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil use
Arm Type
Experimental
Arm Description
Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic
Intervention Description
Use of netarsudil after Descemetorhexis without endothelial keratoplasty
Primary Outcome Measure Information:
Title
Change in central corneal pachymetry over time
Description
Corneal thickness on clinical examination and corneal topography
Time Frame
Measured at post-operative month one visit and then every 2 months for 1 year
Title
Change in endothelial cell count over time
Description
Central endothelial cell count by specular microscopy
Time Frame
Measured at post-operative month one visit and then every 2 months for 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fuchs corneal dystrophy Exclusion Criteria: Women of childbearing potential Other corneal eye diseases Non-compliance with netarsudil Intolerance of netarsudil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma Davies, MD
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sila E Bal, MD, MPH
Organizational Affiliation
Massachusetts Eye and Ear Infirmary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02127
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

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