Real-world Outcomes of Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States.

PURPOSE:This study assessed real-world visual acuity (VA) outcomes of anti-vascular endothelial growth factor (anti-VEGF) therapy for diabetic macular edema (DME). DESIGN:This retrospective analysis was performed on a large database of aggregated, longitudinal electronic medical records from a geographically and demographically diverse sample of patients of United States retina specialists (Vestrum Health Retina Database). PARTICIPANTS:DME patient eyes that underwent ≥3 monthly anti-VEGF injections within 4 months of the first injection and between January 2011 and March 2017 were eligible if follow-up data were available prior to March 2018. METHODS:The eyes were divided into 3 groups based on choice of initial intravitreal anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab). These eyes were then subdivided into 3 cohorts, depending on length of follow-up (6, 12, or 24 months), with each cohort being mutually exclusive. MAIN OUTCOME MEASURES:VA outcomes and number of treatments were assessed on each cohort and stratified by baseline VA. RESULTS:A total of 15,608 DME patient eyes were included in this analysis. In the 12-month cohort, of 1379 eyes initially treated with aflibercept, the mean 12-month improvement was +5.5 letters (95% confidence interval [CI] +4.5 to +6.6 letters, P < 0.001) after 7.5 injections on average, with similar outcomes for bevacizumab (3109 eyes, +5.5 letters, 95% CI +4.7 to +6.3 letters, P < 0.001, average 7.9 injections), and for ranibizumab (1352 eyes, +4.0 letters, 95% CI +2.9 to +5.2 letters, P < 0.001, average 7.7 injections). The mean numbers of corticosteroid, macular, and panretinal laser treatment sessions were similar in each group. In the 12-month cohort, when stratified by baseline VA of 20/201 or worse, 20/71 to 20/200, 20/41 to 20/70, and 20/40 or better, the final mean letters gained or lost were +28.0, +10.2, +2.8, and -2.5 in the aflibercept group, +36.0, +7.8, +2.9, and -2.0 letters in the bevacizumab group, and +30.5, +7.9, +1.6, and -2.7 letters in the ranibizumab group, respectively. CONCLUSIONS:Real-world VA outcomes following anti-VEGF therapy for DME were meaningfully inferior to those noted in randomized, controlled trials. Eyes with better baseline VA experienced fewer letters gained compared with those with worse baseline VA. The initial choice of anti-VEGF agent did not correlate with visual outcomes.