A Study of rhuFab V2 (Ranibizumab) in Subjects With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

Summary

This is a phase III, multicenter, randomized, double masked, sham injection-controlled study of the efficacy and safety of intravitreally administered ranibizumab in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Timeline

Start

2004-08

Primary completion

—

Completion

2007-03

Outcome

Met primary endpoint

paper (P < or = .0001, each ranibizumab dose vs sham). PMID 18222192 ↗

paper Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. PMID 18222192 ↗

Publications

• Results Regillo CD, Brown DM, Abraham P, Yue H, Ianchulev T, Schneider S, Shams N. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER Study year 1. Am J Ophthalmol. 2008 Feb;145(2):239-248. doi: 10.1016/j.ajo.2007.10.004.
• Barbazetto I, Saroj N, Shapiro H, Wong P, Freund KB. Dosing regimen and the frequency of macular hemorrhages in neovascular age-related macular degeneration treated with ranibizumab. Retina. 2010 Oct;30(9):1376-85. doi: 10.1097/IAE.0b013e3181dcfb0b.
• Abraham P, Yue H, Wilson L. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. Am J Ophthalmol. 2010 Sep;150(3):315-324.e1. doi: 10.1016/j.ajo.2010.04.011. Epub 2010 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.3 mg	Intravitreal
Subject	Ranibizumab	Monoclonal antibody	0.5 mg	Intravitreal

Indications