Intravitreal Aflibercept for the treatment of diabetic macular edema in routine clinical practice: results from the 24-Month AURIGA observational study

Introduction AURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) in the treatment of diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion in routine clinical practice. The 24-month outcomes in the DME cohort from across 11 participating countries are reported here.MethodsAURIGA (NCT03161912) was a prospective observational study. The study enrolled eligible patients with DME for whom the decision to treat with IVT-AFL had previously been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month 12 (M12). All statistical analyses were descriptive.ResultsIn 1478 treatment-naive and 384 previously treated patients with DME, the mean (95% confidence interval) change in VA from baseline was +6.7 (5.7, 7.6) and +7.4 (5.5, 9.4) letters by M12 and +5.9 (4.9, 6.9) and +8.1 (6.1, 10.1) letters by M24 (baseline [mean +/- standard deviation]: 56.0 +/- 19.8 and 50.8 +/- 19.5 letters), respectively; 25.9% of treatment-naive and 32.8% of previously treated patients achieved >= 15-letter gains by M24. The mean change in central retinal thickness from baseline to M24 was -110 (-119, -102) mu m in treatment-naive patients and -169 (-188, -151) mu m in previously treated patients. By M6, M12, and M24, treatment-naive patients had received 3.8 +/- 1.7, 4.9 +/- 2.8, and 5.7 +/- 3.9 injections, respectively, and previously treated patients had received 3.9 +/- 1.5, 4.9 +/- 2.4, and 6.2 +/- 3.6 injections, respectively. The safety profile of IVT-AFL was consistent with previous studies.ConclusionIn AURIGA, treatment-naive and previously treated patients with DME achieved clinically relevant functional and anatomic improvements following IVT-AFL treatment for up to 24 months in routine clinical practice. Even with the decreasing injection frequency observed, these gains were largely maintained throughout the study, suggesting long-term durability of the positive effects of IVT-AFL treatment. Infographic available for this article.Trial RegistrationClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017).