First Author: M.Grüb GERMANY
Co Author(s): C. Haritoglou M. Iwersen U. Michel E. Paulus S. Dunker F. Ziemssen
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This observational study is being conducted to describe the utilization of ranibizumab in patients treated according to local routine clinical practice in the approved indications nAMD, DME, BRVO, CRVO and mCNV. Here we will focus on the German DME population.
This is an observational, non-interventional study, conducted to evaluate ranibizumab treatment patterns in real-life conditions. Treatments including diagnoses and monitoring are performed according to routine clinical practice management and per investigator`s discretion. All patients were treated as per the local practice of the participating centres.
This observational, non-interventional study is recruiting up to 5,500 patients in 250 sites in Germany, Switzerland and the Netherlands in the approved indications nAMD, DME, BRVO, CRVO and mCNV. After enrollment of treatment-naïve and pre-treated patients the observational period for each patient is intended to be 24 months.
From 1501 patients, 1439 had baseline documentation and have been followed for further 6 months. Percentage of diagnoses were: nAMD 64%, DME 20%; BVO 8%; CVO 7% and mCNV 1% . Within the subgroup of 291 German DME-patients 45% were female and the average age was 66 years. 41% of patients were treated within German health care contracts. 62% of the population were already pretreated (intravitreal anti-VEGF, intravitreal steroids, PDT, laser). Best corrected visual acuity (BCVA) at baseline was 61.9 (±15.7 letters) for treatment-naïve patients and 67.0 (±15.9 letters) for pretreated patients. 76.8% of treatment-naïve patients and 71.5% of pretreated patients obtained an OCT at baseline. A fluorescein angiography was documented for 73.2% respectively 40.2% patients at baseline. The time between first VA-visit and first injection was 9.6 [±11.7 days (mean)] [5.5 days (median)] for treatment-naïve patients and 13.3 [+/i16.8 days (mean)] [7 days (median)] for pretreated patients.
The observational, non-interventional study PACIFIC provides us with real-life data for therapy with ranibizumab. By observing local routine clinical practice we may obtain a better understanding of how patients are treated in real life settings.