Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284089
Status:
COMPLETED
Last Update Posted:
2011-02-24
First Post:
2006-01-30
Brief Title:
Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
Open-label Multicenter Phase III Study Assessing the Safety and Efficacy of Ranibizumab RFB002 in Japanese Patients With Subfoveal Choroidal Neovascularization CNV Secondary to Age-related Macular Degeneration AMD
Status:
COMPLETED
Status Verified Date:
2011-02
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:
Open-label Multicenter Phase III Study comprising three phases single dose multiple dose and extension phase Assessing the Safety and Efficacy of Ranibizumab RFB002 in Japanese Patients With Subfoveal Choroidal Neovascularization CNV Secondary to Age-related Macular Degeneration AMD
Detailed Description:
The safety and tolerability of single intravitreal injections of ranibizumab was evaluated in patients enrolled in the single dose phase Group A Patients who successfully completed the single dose phase ie did not experience a grade-3 targeted adverse event could enter the multiple dose phase and receive ranibizumab injections for an additional 11 months Simultaneously the multiple dose phase was initiated in two parallel dose groups of additional patients Group B who received ranibizumab injections for 12 months After patients in Group A and Group B had completed the multiple dose phase all patients who provided written consent and were considered eligible based on the inclusion and exclusion criteria of the extension phase had the opportunity to continue on study treatment with the individualized flexible treatment regimen guided by monthly acuity scores and other ophthalmic examinations until approval of ranibizumab in Japan
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