Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040313
Status:
COMPLETED
Last Update Posted:
2006-05-03
First Post:
2002-06-24
Brief Title:
Pegaptanib Sodium Compared to Sham Injection in Patients With DME Involving the Center of the Macula
Sponsor:
Eyetech Pharmaceuticals
Organization:
Eyetech Pharmaceuticals
Study Overview
Official Title:
A Phase II Randomized Controlled Double-Masked Dose-Finding Multi-Center Comparative Trial in Parallel Groups to Establish the Safety and Preliminary Efficacy of Intravitreal Injections of EYE001 Anti-VEGF Pegylated Aptamer Given Every 6 Weeks for 12 to 30 Weeks to Patients With Clinically Significant Diabetic Macular Edema CSME Involving the Center of the Macula
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine whether pegaptanib sodium Macugen is safe and effective in slowing the leakage of fluid within the retina and thereby stabilizing or improving vision when compared to placebo injections A total of 176 patients will be enrolled
Detailed Description:
None
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