Meta Analysis of Stroke Rates using Patient Level Data in Age-Related Macular Degeneration in Patients treated with Ranibizumab
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Steven Butler, Genentech  *Steven Francom, Genentech  Roman Rubio, Genentech 


A meta-analysis of a phase l/ll, 3 phase lll and a phase IIIb large scale safety trial was undertaken for ranibizumab, a treatment for neovascular age-related macular degeneration. Individual studies revealed a slight, but inconsistent pattern of an increased rate of stroke for patients on active treatment, however, the numbers of events were small and none of the differences approached statistical significance. Studies varied in patient population, duration, treatment groups, control groups and treatment regimens. Criteria were developed for pooling studies based on the hypotheses to be tested. Patient level Information is available for strokes and the presence of potential risk factors for stroke. A novel approach for identifying differences in stroke rates among a high risk subset of patients was developed. Sensitivity analyses are provided and complexities in interpretation in addition to limitations of the meta-analyses are discussed. The meta-analysis provides some additional evidence for an increased risk of stroke for subjects on active treatment, but even with the pooled data the numbers of events are too small to allow conclusions to be made. A greater relative difference in rates between active and control subjects was seen in subjects with pre-existing risk factors for stroke, which is consistent with possible increased risk.