Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
Primary Purpose
Fuchs' Endothelial Dystrophy
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Netarsudil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs' Endothelial Dystrophy
Eligibility Criteria
Inclusion Criteria:
- Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
- Is able and willing to administer eye drops
- Is able to comprehend and has signed the Informed Consent form.
Exclusion Criteria:
- Active intraocular inflammation
- Corneal ulceration, keratitis, or conjunctivitis
- Known sensitivity to any of the ingredients in the study medications
- Abnormal eyelid function
- History of herpetic keratitis
- History of non-compliance with using prescribed medication
- Current or planned pregnancy within the study duration
- Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
- Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Sites / Locations
- Price Vision Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Netarsudil
Placebo
Arm Description
Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner
Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.
Outcomes
Primary Outcome Measures
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03971357
Brief Title
Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
Official Title
Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
variance of outcome measures was substantially greater than anticipated in the statistical plan
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
August 26, 2021 (Actual)
Study Completion Date
August 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Price Vision Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
Detailed Description
Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Netarsudil
Arm Type
Experimental
Arm Description
Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.
Intervention Type
Drug
Intervention Name(s)
Netarsudil
Other Intervention Name(s)
Rhopressa
Intervention Description
netarsudil opthalmic solution 0.02%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drops
Primary Outcome Measure Information:
Title
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
Description
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
Is able and willing to administer eye drops
Is able to comprehend and has signed the Informed Consent form.
Exclusion Criteria:
Active intraocular inflammation
Corneal ulceration, keratitis, or conjunctivitis
Known sensitivity to any of the ingredients in the study medications
Abnormal eyelid function
History of herpetic keratitis
History of non-compliance with using prescribed medication
Current or planned pregnancy within the study duration
Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr, MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25299425
Citation
Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270.
Results Reference
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PubMed Identifier
28476048
Citation
Moloney G, Petsoglou C, Ball M, Kerdraon Y, Hollhumer R, Spiteri N, Beheregaray S, Hampson J, D'Souza M, Devasahayam RN. Descemetorhexis Without Grafting for Fuchs Endothelial Dystrophy-Supplementation With Topical Ripasudil. Cornea. 2017 Jun;36(6):642-648. doi: 10.1097/ICO.0000000000001209.
Results Reference
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PubMed Identifier
27310885
Citation
Borkar DS, Veldman P, Colby KA. Treatment of Fuchs Endothelial Dystrophy by Descemet Stripping Without Endothelial Keratoplasty. Cornea. 2016 Oct;35(10):1267-73. doi: 10.1097/ICO.0000000000000915.
Results Reference
background
PubMed Identifier
29384808
Citation
Soh YQ, Mehta JS. Regenerative Therapy for Fuchs Endothelial Corneal Dystrophy. Cornea. 2018 Apr;37(4):523-527. doi: 10.1097/ICO.0000000000001518.
Results Reference
background
PubMed Identifier
30104038
Citation
Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.
Results Reference
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Learn more about this trial
Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
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