Ranibizumab und Aflibercept bei diabetischem Makulaödem – Retrospektive Studie mit Ergebnissen aus dem klinischen Alltag nach 12 Monaten

Abstract

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. Patients with DME involving the fovea in treatment-naïve 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). A total of 41treatment-naïve eyes were identified in 29patients with DME involving the fovea. The mean 12-month improvement was +9.5letters in 19eyes 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 22eyes 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 0.4or less, the mean BCVA improved in 14eyes 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 12.0letters (p < 0.001), in 11eyes 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 17.0letters (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 asignificant difference between the two groups (p = 0.514). In the patients studied ranibizumab and aflibercept showed agood safety and efficacy in the treatment of DME regarding BCVA and CRT under real-life conditions after 12months. In cases of lower initial visual acuity (0.4or 20/50 or less) aflibercept was more effective at improving vision.