First Author: P.Mitchell AUSTRALIA
Co Author(s): J. Gilhotra B. Vote M. Walsh C. Woodcock N. Kurstjens 0 0 0 0 0 0 0 0 0
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LUMINOUS is a global, 5 year multicenter, prospective, observational study to evaluate the long term safety, effectiveness, treatment patterns and health related quality of life outcomes in patients treated with ranibizumab (RBZ) in routine clinical practices. Here we describe the first year interim analysis of 938 patients in the Australian cohort with wet age-related macular degeneration (wAMD).
Nine hundred and thirty eight patients both treatment naive and non-treatment naive to RBZ entered the study between April 2011 and March 2012 and were treated according to current Australian practice protocols. The primary objective was to describe the safety and effectiveness of RBZ in routine clinical practice and secondly, to describe treatment patterns as assessed by overall number of injections, interval between injections and duration of treatment period
Australia contributed 44% of patients within the first global interim analysis. Demographics were consistent with the overall global data set. Female patients were 61.9% (581) of the population and 864 (92.1 %) of patients were Caucasian. Patients already on treatment with RBZ comprised 88.9% of the population. The mean age was 79.5 ± 8.23 years. Seventy five percent of patients were > 75 years old and 30.6% were ≥85 years old. Over the first 12 months, 6326 injections were performed with a mean of 6.7 (± 3.1) per year. Treatment naïve patients had a slightly higher frequency with a mean of 7.3 (±3.7) injections whereas patients previously treated with RBZ had a mean of 6.7 (±2.95) injections, (versus 5.2+3.27 and 5.2+3.32 injections respectively in the global data set). Initial visual acuity (VA) for treatment naïve patients was 50.2 (±21.48) letters, with an average increase of 5.6 (±12.14) letters at 12 months (global data set: baseline 52.4+20.59, 12 months. Patients who were non-treatment naïve maintained VA at 12 months (-0.9 (±11.85) from a baseline of 63.7 (±18.15) letters). Thirteen (1.39%) patients died during the study period. Five (0.53%) patients reported ocular serious adverse events (SAEs) and 62 (6.61%) reported non-ocular SAEs.
This first year interim data describes the real world use, safety and effectiveness of ranibizumab from a large patient cohort in Australia. Ranibizumab was efficacious in treating both treatment naïve and treatment non-naïve patients. The number of injections required by both groups is similar to that reported in other real world studies and better reflects the current treatment practice in Australia. The data here suggest that ranibizumab is very well tolerated with no new safety signals.