Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT00138632
Status:
COMPLETED
Last Update Posted:
2008-11-14
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Sponsor:
Novartis
Organization:
Study Overview
Official Title:
A Randomized, Double-Masked, Multicenter, Phase I/II 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 verteporfin/PDT 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 verteporfin/PDT 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: