A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
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|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)|
|Estimated 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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00251459
|Study Director:||Tsontcho Ianchulev, M.D.||Genentech, Inc.|