RESUMO
PURPOSE: Treatment with intravitreal injections of anti-vascular endothelial growth factors, like aflibercept, has revolutionized the management of diabetic macular edema. The purpose of this study is to evaluate the 2-year results of treatment with aflibercept in newly diagnosed, treatment-naive patients with diabetic macular edema in a real-life setting in a tertiary hospital of Southwestern Greece. METHODS: In this retrospective, real-life, single-center, cohort study the records of diabetic patients were reviewed. In the study we included treatment naive eyes that started treatment with intravitreal injections of aflibercept in the Department of Ophthalmology of the University Hospital of Patras. The scheduled treatment regimen of aflibercept was based on the Summary of Product Characteristics of the product and included a loading dose of 5 monthly aflibercept injections followed by bimonthly treatment until the completion of the first year. During the second year a treat and extend treatment regimen was applied. We recorded data such as age, gender, number of visits and injections, best corrected visual acuity (BCVA) and central macular thickness (CMT) as it was evaluated by a spectral domain optical coherence tomography (SD-OCT). RESULTS: Thirty treatment-naive eyes of 22 patients (14 male, 8 female) received treatment with aflibercept for at least 1 year during the period between January 2017 and August 2019. The mean age of the patients was 68.64±7.35 years. Ninety percent of the patients suffered from type-II diabetes and 9% from type-I. The median time between the diagnosis of diabetic macular edema and initiation of treatment with intravitreal injections of aflibercept was 0.5 months (range 0-3 months). Median baseline logMAR BCVA was 0.398 (range 0.046-1.301). The mean CMT at baseline was 388.0±162.94µm. Over a period of 12 months, and after a mean number of 7.5±2.3 visits, patients received a mean number of 7±1.12 intravitreal injections of aflibercept. Eighteen eyes (60%) received an induction phase with 5 monthly injections according to aflibercept SPC. After 12 months the median BCVA (0.324, range 0.0-1.3) was statistically significantly better compared to baseline (p=0.024) and the CMT (295.67±70.99) was significantly lower compared to baseline (p=0.017). Eighteen eyes (60%) completed 2 years of treatment with aflibercept. Over the 2-year period patients made a mean number of 12.7±3.08 visits and received a mean number of 10.2±1.64 intravitreal injections of aflibercept. The median logMAR BCVA at 2 years (0.301, range 0-0.52) was statistically significantly better compared to baseline (p=0.013) and the CMT (293.53±65.93) was significantly lower compared to baseline (p=0.01). No serious adverse events were recorded during this period. CONCLUSION: Aflibercept resulted in significant functional and anatomic improvement after 12- and 24-month treatment in diabetic macular edema eyes in a real-life setting. The majority of the eyes completed the 2-year treatment regimen of aflibercept.