Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403156
Status:
WITHDRAWN
Last Update Posted:
2015-12-31
First Post:
2006-11-22
Brief Title:
Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Sponsor:
Vitreous -Retina- Macula Consultants of New York
Organization:
Vitreous -Retina- Macula Consultants of New York
Study Overview
Official Title:
A Phase I Study of the Inhibition of Platelet Derived Growth Factor Using Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of study is to determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization
Detailed Description:
This is an open-label dose escalating study n15 to evaluate the safety and tolerability of the addition of imatinib mesylate to the Lucentis treatment regime over a 6 month period in patients with newly diagnosed choroidal neovascularization
5 patients will be treated with 4 weeks of imatinib mesylate 400mg per day the lowest typical starting dose to be started concurrently with ranibizumab Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
If imatinib mesylate is safely tolerated for the first 4 weeks the following set of 5 patients will be treated with 6 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
If imatinib mesylate is safely tolerated for the first 6 weeks the following set of 5 patients will be treated with 8 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
5 patients will be treated with 4 weeks of imatinib mesylate 400mg per day the lowest typical starting dose to be started concurrently with ranibizumab Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
If imatinib mesylate is safely tolerated for the first 4 weeks the following set of 5 patients will be treated with 6 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
If imatinib mesylate is safely tolerated for the first 6 weeks the following set of 5 patients will be treated with 8 weeks of imatinib mesylate 400mg per day to be started concurrently with Lucentis 05mg intravitreal injection The patients would be injected at monthly intervals for the first 3 months followed by treatment on an as needed basis
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