Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00379795
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2006-09-21
Brief Title:
An Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization Secondary to AMD or Macular Edema Secondary to RVO
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
An Open-Label Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization CNV Secondary to Age-Related Macular Degeneration AMD or Macular Edema Secondary to Retinal Vein Occlusion RVO Who Have Completed a Genentech-Sponsored Ranibizumab Study
Status:
COMPLETED
Status Verified Date:
2017-04
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 was an open-label multicenter extension study of intravitreally administered ranibizumab in two cohorts The first cohort reported here enrolled patients with primary or recurrent Choroidal Neovascularization CNV secondary to Age-Related Macular Degeneration AMD who completed the treatment phase of a Genentech sponsored study FVF2598g NCT00056836 FVF2587g NCT00061594 or FVF2428g NCT00056823 The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion RVO who completed the 6-month treatment and 6-month observation phases 12 months total of a Genentech sponsored study FVF4165g NCT00486018 or FVF4166g NCT00485836 The results of the second cohort are reported separately NCT01442064 The first cohort of this study enrolled two subsets of patients ranibizumab experienced and ranibizumab-naive Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study
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