Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01445028
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2011-09-29
Brief Title:
Isotretinoin for Proliferative Vitreoretinopathy
Sponsor:
Wills Eye
Organization:
Wills Eye
Study Overview
Official Title:
Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DELIVER
Brief Summary:
Proliferative vitreoretinopathy PVR or secondary scarring on and around the retina is an important cause of retinal re-detachment The purpose of this study is to evaluate the effect of oral isotretinoin which inhibits the growth of cells responsible for proliferative vitreoretinopathy PVR on recurrent retinal detachment
Detailed Description:
Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR This is a prospective study to evaluate a low dose of oral isotretinoin in this regard There are two arms to the study 1 eyes with recurrent retinal detachment due to existing PVR and 2 eyes with primary detachment and features associated with a high risk of PVR formation Eligible and willing patients will receive a 12-week course of isotretinoin and will be followed for retinal attachment rate and PVR andor ERM epiretinal membrane formation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None