Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320788
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2006-04-28
Brief Title:
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor VEGF Trap in Patients With Wet Age-Related Macular Degeneration AMD
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Controlled Study of the Safety Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2012-01
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:
None
Brief Summary:
This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD
The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization CNV due to AMD
The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization CNV due to AMD
Detailed Description:
This is a double masked prospective randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal IVT injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period
After Week 12 patients will be evaluated every 4 weeks Patients will remain on study or may be eligible to enter a long-term extension study in which they will continue to receive VEGF Trap
After Week 12 patients will be evaluated every 4 weeks Patients will remain on study or may be eligible to enter a long-term extension study in which they will continue to receive VEGF Trap
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