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Paul Mitchell, LUMINOUS Study Group; Ranibizumab in the real world clinical setting: results from the one year interim analysis of the LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3062.
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© ARVO (1962-2015); The Authors (2016-present)
To present one year data from the first cohort of wet age related macular degeneration (wAMD) patients recruited in the LUMINOUS study
LUMINOUS is an ongoing 5-year prospective, multinational, observational study across all approved indications of ranibizumab, designed to evaluate long-term safety, effectiveness, treatment patterns, and health-related quality of life outcomes in patients treated with ranibizumab 0.5 mg in routine clinical practice. The study aims to enroll 30,000 patients from approximately 600 sites in 41 countries worldwide. Of the 2163 patients recruited prior to or on 1st March 2012, 97.6% had wAMD, 1.7% diabetic macular edema and 0.6% retinal vein occlusion. Here, we present the one year safety and effectiveness data for the wAMD cohort (n=2112), of whom 1829 patients had previous ranibizumab treatment (T1), and 275 patients had no prior ranibizumab treatment (T2). 8 patients were previously managed with other ocular treatments (pre-treatment status defined by the primary treated eye)
At baseline, mean age was 79.2 years, 61.7% were female, 93.0% were Caucasian. Mean visual acuity (VA), as early treatment diabetic retinopathy study (ETDRS) letter scores, was higher and central retinal thickness (CRT) was lower for T1 than T2 at baseline (letter scores 60.3 and 52.4, CRT 255.0 and 339.7 µm, respectively). There were no new safety findings reported at the end of the first year, with low rates of ocular (0.4% [T1]; 1.1% [T2]) and non-ocular serious adverse events (8.26% [T1]; 4.73% [T2]). Low rates of endophthalmitis (0.11% [T1]; 0.36% [T2]), cerebrovascular accident (0.22% [T1]; 0.36% [T2]) and myocardial infarction (0.66% [T1]; 0% [T2]) were observed. None of the 37 deaths during the first year of the study (1.7%) were suspected to be related to study drug/injection procedure. At year one, T2 group letter score gain was 4.1 letters, whilst the T1 group maintained their initial higher baseline level VA (-1.1 letter score change). T1 and T2 groups received a mean of 5.2 injections over 7.4 and 7.5 visits, respectively
The outcomes from the first year follow up of LUMINOUS wAMD patients in real-world settings reinforce the well-established efficacy and safety profile of ranibizumab. No new safety findings were observed in this first one year interim analysis of the LUMINOUS study
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