Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021736
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-08-03
Brief Title:
Phase IIIII Study of Anti-VEGF in Neovascular AMD
Sponsor:
Eyetech Pharmaceuticals
Organization:
Eyetech Pharmaceuticals
Study Overview
Official Title:
Phase IIIII Randomized Double-Masked Trial to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 Anti-VEGF Pegylated Aptamer Given Every 6 Weeks for 54 Weeks in Patients With Exudative AMD
Status:
COMPLETED
Status Verified Date:
2002-07
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 the anti-VEGF drug is effective at stabilizing andor improving vision in patients with the wet form of AMD
Detailed Description:
This will be a randomized double-masked controlled dose-ranging multi-center comparative trial in parallel groups Patients will be stratified by clinical center by percentage of classic CNV vessels predominantly classic 50 vs minimally classic 1-49 vs purely occult 0 and according to whether or not they have received prior PDT with Visudyne no more than once All patients will be re-randomized after 54 weeks of treatment to either continue or discontinue therapy for further 48 weeks
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