A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
|ClinicalTrials.gov Identifier: NCT00251459|
Recruitment Status : Completed
First Posted : November 10, 2005
Last Update Posted : March 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Choroidal Neovascularization Age-related Macular Degeneration||Drug: rhuFab V2 (ranibizumab)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||5000 participants|
|Official Title:||A Phase IIIb, Single-Masked, Multicenter, Randomized Study to Evaluate the Safety and Tolerability of Ranibizumab in Naive and Previously Treated Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)|
|Study Start Date :||November 2005|
|Actual Study Completion Date :||September 2007|
U.S. FDA Resources
- Cohort 1: The primary safety outcome measure is the incidence of SAEs (ocular and non ocular) evaluated through Month 12.
- Cohort 2: The primary safety outcome measure is the incidence of SAEs (ocular and non-ocular) and AEs (ocular and non-ocular) evaluated through Month 12.
- Incidence of AEs (ocular and non-ocular) evaluated through Month 12
- Proportion of subjects who lose at least 15 letters in BCVA at Month 12 compared with baseline
- Mean time to retreatment following the initial three monthly loading doses
- Mean total number of injections through Month 12.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251459
|Study Director:||Tsontcho Ianchulev, M.D.||Genentech, Inc.|