Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429962
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2007-01-31
Brief Title:
Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Randomized Phase IIIb Study Comparing Safety Tolerability and Efficacy Between Lucentis Administered in Conjunction With PDT With Visudyne and Lucentis in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2009-04
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 pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy Visudyne compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD
Detailed Description:
Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD However the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections Ranibizumab is an anti-VEGF-A monoclonal antibody fragment Verteporfin photodynamic therapy acts through occluding newly formed vessels The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintainingimproving the increase in vision improvement observed with ranibizumab monotherapy The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy
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