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Francesco Bandello, Frank G. Holz, Mark C. Gillies, Adrian Koh, Paul Mitchell, LUMINOUS group; Safety, Efficacy, And Treatment Patterns Of Ranibizumab Therapy For Neovascular Age-Related Macular Degeneration: The LUMINOUS Studies. Invest. Ophthalmol. Vis. Sci. 2012;53(14):2031.
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To report on the LUMINOUS program including a retrospective pooled safety analysis of ranibizumab in European registries with neovascular age-related macular degeneration (nAMD) patients and the prospective study designed to assess long-term safety, efficacy, treatment patterns, and health-related quality of life outcomes in a large number of patients treated with ranibizumab in routine clinical practice across the world.
Retrospective analysis: Four nAMD registries from Germany (n=3470), the Netherlands (n=243), Belgium (n=260), and Sweden (n=471) were completed and included in this retrospective analysis. The 12-month treatment exposure and 12-month incidences (% of patients) of targeted adverse events were assessed over all the registries. The study design of the prospective study (www.clinicaltrials.gov, NTC01318941) is presented.
Retrospective analysis: 4444 patients were included in the analysis. The mean number of ranibizumab injections ranged from 4.3 to 5.7 over 12 months. Over all registries, the targeted adverse events were associated with the following incidences during the 12-month follow-up period: 0.11% endophthalmitis, 0.07% intraocular inflammation, 0.23% cataract, 0.50% elevated intra-ocular pressure, 0.14% reduced retinal blood flow, 0.02% retinal tear, 0.02% retinal detachment, 0.61% retinal pigment epithelial tear, 0.18% vitreous hemorrhage, 0.18% hypersensitivity, 0.16% hypertension, 0.11% non-ocular hemorrhage, 0.11% myocardial infarction, 0.59% arterio-thromboembolic events, and 0.11% venous thromboembolic events. The prospective study is an ongoing global five year non-interventional, multicenter study in patients being treated with ranibizumab.
The retrospective pooled analysis of European registries shows no new safety risks. A low number of ranibizumab injections in nAMD during the first year was noted. The ongoing LUMINOUS study further aids the characterization of both safety and efficacy profiles in addition to understanding treatment patterns and other outcomes achieved with ranibizumab in routine clinical practice.
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