Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-09 @ 2:17 PM
Study NCT ID:
NCT03971357
Status:
TERMINATED
Last Update Posted:
2023-02-06
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
Sponsor:
Price Vision Group
Organization:
Study Overview
Official Title:
Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
variance of outcome measures was substantially greater than anticipated in the statistical plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: