A retrospective, real-world evidence study of patients with neovascular age-related macular degeneration in the USA

Abstract Objective To characterize real-world baseline visual acuity (VA) and anti-vascular endothelial growth factor (VEGF) treatment patterns in US neovascular age-related macular degeneration (nAMD) patients between 2012 and 2015. Design Retrospective, multicenter, non-interventional real-world evidence study. Participants A total of 98 821 eyes from 79 885 patients receiving intravitreal anti-VEGF therapy. Methods Up to 5 years of routinely collected, anonymized patient data was remotely extracted from 58 US centers to a central database using an electronic medical record system. Main outcome measure Baseline VA, VA change from baseline, treatment frequencies, annual anti-VEGF injections, bilateral treatment frequencies, annual total clinic visits and non-injection clinic visits. Results Baseline characteristics were comparable across years. Similar mean (SD) baseline VA for 2012, 2013, and 2014 (53.6 [23.3], 53.2 [23.4], 53.1 [23.6] ETDRS letters, respectively), but lower for 2015 (50.7 [24.4]). In eyes with 4-year follow-up, VA changes from baseline (LS mean [95%CI]) were +1.1 (1.0;1.3), -1.3 (-1.5;-1.0), -3.1 (-3.5;-2.7) and -5.2 (-6.0;-4.3) ETDRS letters for years 1–4, respectively. Mean (SD) number of injections was 7.5 (1.9), 6.7 (2.1), 6.6 (2.3) and 6.4 (2.3) for Years 1–4, respectively. By Year 4, 36.7% of eyes had ≤8-week dosing intervals (q8w) and 21.2% had ≥12-week dosing intervals. Eyes treated Conclusions This real-world study describes the treatment burden, initiation and monitoring patterns and VA outcomes at a scale and timeframe that has not previously been reported. In this cohort, baseline VA was similar for the index years 2012–2014, but lower for 2015. In patients with 4-year follow-up, both VA and injection frequency declined, whereas the proportion of eyes treated more frequently than the recommended q8w dosing interval increased. The reduction in dosing intervals may be a consequence of intensification of treatment due to year-on-year VA loss and disease progression.