Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390026
Status:
WITHDRAWN
Last Update Posted:
2024-01-31
First Post:
2006-10-17
Brief Title:
The Avastin vs Visudyne for Neovascular AMD Study
Sponsor:
St Erik Eye Hospital
Organization:
St Erik Eye Hospital
Study Overview
Official Title:
A Prospective Randomized Double-masked Controlled Study on Intravitreal Bevacizumab Avastin Versus Verteporfin Visudyne Photodynamic Therapy PDT for Patients With Neovascular Age-related Macular Degeneration AMD
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lucentis a treatment superior to PDT has become available i Sweden
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The object of the study is to compare the treatment effect of bevacizumab Avastin an antibody targeting vascular endothelial growth factor with verteporfin photodynamic therapy PDT for patients with neovascular age-related macular degeneration the leading cause of vision severe loss in the Western world
Detailed Description:
Neovascular age-related macular degeneration AMD is caused by an ingrowth of pathological vessels under the macula Experimental studies have demonstrated that vascular endothelial growth factor VEGF is centrally involved in this process Current treatment options have up until now been limited to photodynamic therapy PDT where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective randomized and controlled trial including 100 patients 50 patients receiving either treatment regimen Non-treated patients will receive either sham-injection or sham-PDT The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart The study will go on for 2 years with an interim report after 1 year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU2006-001200-36 | None | None | None |