SIERRA-AMD: A Retrospective, Real-World Evidence Study of Patients with Neovascular Age-Related Macular Degeneration in the United States

PURPOSE:Characterize real-world baseline visual acuity (VA) and anti-vascular endothelial growth factor (VEGF) treatment patterns in neovascular age-related macular degeneration patients in 2012-2015. DESIGN:Retrospective, multicenter, noninterventional real-world evidence study. PARTICIPANTS:A total of 98 821 eyes from 79 885 patients receiving intravitreal anti-VEGF therapy. METHODS:Anonymized patient data routinely collected over 5 years were extracted from 58 United States centers to a central database using an electronic medical records system. MAIN OUTCOME MEASURES:Baseline VA, VA change from baseline, treatment frequencies, annual anti-VEGF injections, bilateral treatment frequencies, annual total clinic visits, and noninjection clinic visits. RESULTS:Baseline characteristics were comparable across years. Baseline VAs (Mean±standard deviation [SD] Early Treatment Diabetic Retinopathy Study [ETDRS] letters) were similar for 2012, 2013, and 2014 (53.6±23.3, 53.2±23.4, and 53.1±23.6, respectively), but was lower for 2015 (50.7±24.4). In eyes with 4-year follow-up, VA changes from baseline (ETDRS letters) were least squares means of +1.1 (95% confidence interval [CI], 1.0;1.3), -1.3 (95%CI, -1.5;-1.0), and -3.1 (95%CI, -3.5;-2.7), and -5.2 (95%CI, -6.0;-4.3) for years 1-4. 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. By year 4, 36.7% of eyes had ≤8-week dosing intervals (q8w) and 21.2% had ≥12-week dosing intervals. Eyes treated q8w increased 40% from Year 1 (32.4%) to Year 4 (45.3%). Baseline bilateral treatment frequency was 6.1%. Of the patients treated bilaterally, 32.0% received the first treatment in the better-seeing eye, and 68.0% received first treatment in an eye with vision the same as or worse than the fellow-eye. This trend was evident across all index years. CONCLUSIONS:This real-world study describes the treatment burden, initiation and monitoring patterns, and VA outcomes at a scale and timeframe that has not been previously 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 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.