RESUMEN
PURPOSE: To assess the effectiveness and safety of intravitreal aflibercept in clinically significant diabetic macular edema (DME) in daily clinical practice. METHODS: Prospective, open-label, single-center study. Anti-vascular endothelial growth factor naïve patients with clinically significant DME received intravitreal injections of aflibercept 2 mg, five monthly doses followed by a fixed schedule every 2 months for 12 months. The mean change in best-corrected visual acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) was the primary outcome. RESULTS: The mean BCVA improved significantly as compared with baseline at 12 months of treatment (47.3 [14.2] vs 62.2 [13.9] ETDRS letters, P<0.001). Significant improvement in BCVA was already observed at visit 2 after the loading doses of aflibercept. At 12 months, gains in ETDRS letters were documented in all eyes (100%), with gains ≥10 letters in 89.6%, ≥15 letters in 65.5%, and ≥20 letters in 6.9% (n=2). A significant reduction in central macular thickness from a mean of 460.5 (11.8) µm at baseline to 229.0 (43.8) µm at 12 months (P<0.001) was observed. Significant reductions of central macular thickness were already observed after the loading doses and continued lowering throughout the study period. No adverse events occurred. CONCLUSION: Aflibercept as a first-line therapy was effective and well tolerated for treating clinically significant DME in naïve patients in daily practice. Successful results in terms of improvement of visual and reduction in central macular thickness contribute to provide evidence for the positioning of aflibercept as a first-line indication of newly diagnosed clinically significant DME.