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D.S. Boyer, MIRA–1 Study Group; Rheopheresis for Dry AMD: Efficacy and Safety Analysis of the Pivotal MIRA–1 Clinical Trial . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2176.
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Rheopheresis is an application of double filtration plasmapheresis specifically designed to treat microcirculatory disorders. There are several possible ways that Rheopheresis may affect the microcirculation and subsequent function of the retina. It may modify the diffusion characteristics of Bruch’s membrane, the rheology of the choriocapillaris, impact an inflammatory cascade or a combination of these.
The multicenter, double masked, placebo (sham–apheresis) controlled randomized MIRA–1–trial has been completed to evaluate safety and efficacy of Rheopheresis for dry AMD with soft drusen through the 12 month post baseline visit (for interim analysis see Pulido et al. Trans Am Ophthalmol Sci 2002; 100: 85–108).
Patients included in the MIRA–1 pivotal trial are scheduled to be unmasked in February 2006 when all data has been checked for accuracy and completeness. This report will document whether the MIRA–1 study achieved its primary efficacy endpoint, a statistically significant improvement in best corrected acuity from baseline to postoperative visits (3,6, 9 and 12 months post baseline) in the actively treated group when compared to placebo. Statistical analysis will be performed using repeated measures analysis.
Results of these clinical trials provides a direct transfer of evidence–based medicine into clinical practice as Rheopheresis, based upon the preliminary interim analysis, appears to offer a clinical treatment for the progressively deteriorating natural course of Dry AMD.
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