[Treatment reality with ranibizumab in clinical routine use for patients with diabetic macular edema : 1‑year results of the German POLARIS cohort].

BACKGROUND

Currently only few data are available on the treatment reality with ranibizumab in patients with diabetic macular edema (DME).

MATERIAL AND METHODS

POLARIS is an international observational study which included 983 patients who were treated with ranibizumab due to DME. The primary objective of the study was to investigate the influence of treatment and control intervals as well as resource utilization on the mean change in visual acuity. Secondary endpoints included the collation of disease activity monitoring in the clinical practice. This article describes the results of the German POLARIS population. The study was conducted in 8 European countries from October 2012 to January 2015.

RESULTS

In Germany 220 patients were included in the study. Visual acuity improved by 4.3 letters within the first 3 months of treatment. At 12 months, visual acuity increased on average by 4.1 (SD ± 12.4) letters (approximately 1 line) for 168 patients enrolled in the efficacy analysis. Patients received an average of 4.5 (SD ± 1.9) injections, 10.3 (SD ± 6.3) visual acuity tests and 3.3 (SD ± 3.1) optical coherence tomography (OCT) examinations during the first year. Patients with ≤3 injections showed an average improvement in visual acuity by 2.7 letters which was less improvement compared to patients with >3 injections, who achieved an average improvement of 5.4 letters. There was a correlation between the number of injections and the visual acuity achieved.

DISCUSSION

For Germany, the results of the POLARIS study indicate that despite a high number of visits, patients with DME are undertreated in clinical routine practice. The injection frequency in Germany was lower than in randomized clinical trials. Almost half of the patients received less than 4 injections in the first year of treatment and thus showed an undertreatment compared to the recommendations of German and international medical societies.