Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138632
Status:
COMPLETED
Last Update Posted:
2008-11-14
First Post:
2005-08-29
Brief Title:
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration AMD
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-Masked Multicenter Phase III Study of the Safety of PTK787 Administered to Patients With Predominantly Classic Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2008-11
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:
ADVANCE
Brief Summary:
This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily It also explores the efficacy of the compound in patients with wet age-related macular edema
In Cohort 1 verteporfinPDT is the active control The protocol was amended to reflect the current standard of care for AMD As a result ranibizumab is the active control for Cohort 2
In Cohort 1 verteporfinPDT is the active control The protocol was amended to reflect the current standard of care for AMD As a result ranibizumab is the active control for Cohort 2
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