Two Year Visual Acuity and Structural Outcomes in Patients with Diabetic Macular Oedema Treated with Intravitreal Aflibercept - A Retrospective Cohort Study

Purpose: To assess visual and anatomical outcomes of intravitreal aflibercept for clinically significant diabetic macular oedema (DME). Methods: For this retrospective single-center cohort study at a tertiary referral center, we performed a data warehouse query to identify 117 treatment-naive patients (139 eyes) undergoing intravitreal treatment with aflibercept for DME between January 2014 and May 2018. Changes in best-corrected visual acuity (BCVA) values (as measured with ETDRS letters), central retinal thickness (CRT) and total macular volume (TVOL) are reported over a two-year period at various time-points. Results: The total number of injections per study eye was 5.5 +/- 1.4 after one and 8.7 +/- 2.2 injections after two years. Baseline visual acuity (VA) was 60.1 +/- 14.5 letters. A gain of 4.8 and 9.2 letters from baseline was observed after one and two years, respectively (both p = 0.01). In comparison to the mean CRT at baseline (419 +/- 174 mu m), a CRT decrease was observed after one and two years of treatment (298 +/- 115 mu m and 319 +/- 119 mu m, respectively; both p = 0.01). Similarly, TVOL decreased from 10.12 +/- 2.05 mm(3) to 8.96 +/- 0.96 mm(3) and 9.01 +/- 1.29 mm(3) (both p = 0.01). Conclusion: This study demonstrates that treating DME with intravitreal aflibercept yields positive functional and structural outcomes over a two-year period. However, we observed fewer injection numbers, along with inferior VA and structural outcomes than has been reported in randomized clinical trials. Our results show similar results as in patients treated with ranibizumab due to DME in real-life settings.