Ignite Creation Date:
2024-05-06 @ 12:29 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01589718
Status:
WITHDRAWN
Last Update Posted:
2014-03-05
First Post:
2012-04-27
Brief Title:
A Study of the Safety Tolerability and Efficacy of IVT Pre-op 03mg Pegaptanib Sodium Versus Sham for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy
Sponsor:
Greater Houston Retina Research
Organization:
Greater Houston Retina Research
Study Overview
Official Title:
A Phase III Randomized 11 Masked Study of the Safety Tolerability and Efficacy of Intravitreal Pre-op 03mg Pegaptanib Sodium Versus Sham for Adjuvant Management of TRD and Vit Hem Associated With PDR
Status:
WITHDRAWN
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patients were enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
No-Crunch01
Brief Summary:
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment
Detailed Description:
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 03mg Macugen prior to surgery versus sham injection
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule
Some photos may be limited secondary to vitreous hemorrhage Follow up visits after surgery will be one day one week one month and three months
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule
Some photos may be limited secondary to vitreous hemorrhage Follow up visits after surgery will be one day one week one month and three months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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