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Sanjay Sharma, ; Baseline characteristics of Canadian patients with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) enrolled in the LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5356.
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© ARVO (1962-2015); The Authors (2016-present)
LUMINOUS (NCT01318941) is an ongoing, 5-year multicenter, observational study to evaluate the long-term safety, effectiveness, treatment patterns and health-related quality-of-life associated with ranibizumab (RBZ) treatment in clinical practice for all licensed indications. Here, we describe the baseline characteristics of the enrolled Canadian nAMD, DME and RVO patients.
Of the 20085 adult patients enrolled globally prior to March 2014, 2011(10%) were Canadian: 1560 (78%) nAMD, 319 (16%) DME and 130 (6.5%) RVO patients. Both treatment naïve and prior RBZ patients were enrolled.
In Canada the mean age of nAMD, DME, BRVO and CRVO patients was 80 yrs (31% >85 yrs), 66 yrs, 73 yrs and 71 yrs, respectively. Baseline VA (ETDRS letter score) was higher in the prior RBZ patients than in the treatment naïve group in all indications (nAMD 55.9 vs 49.4, DME 62.5 vs 61, BRVO 56.5 vs 53.9, and CRVO 55.5 vs 40.2). Baseline VAs were similar in the global and Canadian cohorts, with the exception of DME (treatment naïve: 62.5 vs 57.8, prior-RBZ: 61.0 vs 55.5, respectively) and CRVO prior-RBZ where the global cohort had a lower baseline VA than the Canadian (49.8 vs 55.5). Non ocular comorbidities in Canadian patients were similar to the global cohort across all indications with the exception of myocardial infarction (8.8% vs 6.9%), hypertension (60.5% vs 59.1%) and history of coronary artery disease (27.7% vs 17.2%)
LUMINOUS includes patients with more diverse demographics than typically reported for clinical trials, and is more representative of the real world patient population. Prior RBZ treatment was associated with numerically higher VA than the treatment naïve group. Analyses of LUMINOUS study data are expected to provide substantial evidence on the long-term safety, effectiveness, and treatment patterns of ranibizumab in routine clinical practice.
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