Abstract
Purpose:
Clinical studies demonstrate that optimal outcomes are achieved with monthly ranibizumab treatment for wet, age-related macular degeneration (wAMD). In clinical practice, in order to reduce management burdens, as-needed or treat-and-extend dosing regimens have been adopted. The AURA study examines the real-world utilization and related outcomes of ranibizumab.
Methods:
Retrospective, international (Canada, France, Germany, Ireland, Italy, Netherlands, UK, Venezuela), non-interventional, observational study. Target enrollment was 444 patients per country. Consecutive AMD patients who were prescribed ranibizumab by their physicians and started treatment between January 1, 2009, and August 31, 2009, were included, with a follow-up period of up to 2.5 years. Primary outcomes were change in visual acuity and resource utilization (number of treatment and monitoring visits, treatment use). Data are presented as descriptive statistics.
Results:
253, 489, 454, 53, 445, 436, 490, and 49 patients were enrolled from Canada, France, Germany, Ireland, Italy, Netherlands, UK, and Venezuela, respectively. To date, results for France and Germany are available. The mean change in visual acuity from baseline at Year 1 and Year 2 was 0.8 ± 17.3 and 0.1 ± 18.2 letters, respectively, in France, and -0.4 ± 16.0 and -2.4 ± 17.7 letters, respectively, in Germany. The mean number of monitoring visits was 8.5 in Year 1 and 4.9 in Year 2 in France, and 7.8 and 3.1, respectively, in Germany. The mean number of treatment visits was 4.7 in Year 1 and 2.1 in Year 2 in France, and 4.5 and 1.4, respectively, in Germany. The mean number of injections was 4.4 in Year 1 and 1.9 in Year 2 in France, and 4.2 and 1.1, respectively, in Germany. The clinical management, utilization patterns, and outcomes obtained with the use of ranibizumab for the treatment of wAMD from the remaining countries will also be presented.
Conclusions:
The data show that in France and Germany patients undergoing treatment with ranibizumab for wAMD are, on average, having poorer than expected visual outcomes due to less than monthly monitoring and low numbers of treatments per year. Even though these results are much better than the untreated evolution of the disease, consideration should be given to closer adherence to published clinical trial protocols, to try to improve visual outcomes in wAMD patients.