Ranibizumab and aflibercept for diabetic macular edema-retrospective study with real-life data after 12 months

Background. Currently only few data are available on a direct comparison of the treatment reality with ranibizumab and aflibercept in patients with diabetic macular edema (DME). This study assessed best corrected visual acuity (BCVA) outcomes and central retinal thickness (CRT) under treatment with ranibizumab and aflibercept. Material and methods. Patients with DME involving the fovea in treatment-naive eyes and a follow-up period of least 12 months were retrospectively identified. Patients underwent treatment with ranibizumab 0.5 mg or aflibercept 2.0 mg. The findings were obtained using clinical examination, fluorescein angiography and spectral domain optical coherence tomography (SD-OCT, measuring CRT). Results. A total of 41 treatment-naive eyes were identified in 29 patients with DME involving the fovea. The mean 12-month improvement was +9.5 letters in 19 eyes treated with ranibizumab and BCVA improving from 0.57 log MAR (95% confidence interval, CI 0.45-0.70 log MAR) to 0.38 log MAR (95% CI 0.25-0.50 log MAR; p < 0.001) and +8.5 letters in the aflibercept group with 22 eyes and BCVA improving from 0.38 log MAR (95% CI 0.25-0.51 log MAR) to 0.21 log MAR (95% CI 0.08-0.34 log MAR; p < 0.001). The difference between the two groups was not statistically significant (p = 0.599). When the initial visual acuity was 0.4 or less, the mean BCVA improved in 14 eyes treated with ranibizumab from 0.62 log MAR (95% CI 0.47-0.79 log MAR) to 0.38 log MAR (95% CI 0.21-0.55 log MAR), an improvement of 12.0 letters (p < 0.001), in 11 eyes treated with aflibercept from 0.63 log MAR (95% CI 0.42-0.84 log MAR) to 0.29 log MAR (95% CI 0.08-0.50 log MAR), an improvement of 17.0 letters (p < 0.001). The difference between the two groups was significant (p < 0.001). The mean number of intravitreal injections was 6.4 (95% CI 5.1-7.7) in the ranibizumab group, 7.5 (95% CI 6.2-8.8) in the aflibercept group (p= 0.199). The mean CRT decreased significantly (p < 0.001) in patients treated with both ranibizumab and aflibercept without any evidence of a significant difference between the two groups (p= 0.514). Discussion. In the patients studied ranibizumab and aflibercept showed a good safety and efficacy in the treatment of DME regarding BCVA and CRT under real-life conditions after 12 months. In cases of lower initial visual acuity (0.4 or 20/50 or less) aflibercept was more effective at improving vision.