A Study to Evaluate Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
This study has been completed.
Information provided by:
First received: November 8, 2005
Last updated: November 11, 2010
Last verified: November 2010
This is a Phase IIIb, single-masked, 1-year multicenter study of the safety and tolerability of intravitreally administered ranibizumab in subjects with active subfoveal CNV secondary to AMD.
Age-Related Macular Degeneration
Drug: rhuFab V2 (ranibizumab)
|Study Design:||Primary Purpose: Treatment|
|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)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Genentech:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
|Study Start Date:||November 2005|
|Study Completion Date:||September 2007|
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