gms | German Medical Science

Goal: In the management of mCNV, several clinical studies demonstrated ranibizumab efficacy and safety, however, few prospective studies have investigated mCNV patients in a real-life setting. PACIFIC is an observational, non-interventional study recruiting up to 5,500 patients in 250 sites in Germany, Switzerland and the Netherlands in the approved indications nAMD, DME, BRVO, CRVO and CNV. It is conducted to evaluate ranibizumab treatment patterns in real-life conditions according to local routine clinical practice in all approved indications. Here, we present an interim sub-analysis of the German mCNV population.

Method: Treatment, diagnosis and monitoring are performed according to routine clinical practice management, to the local practice of the participating centers and the investigator’s discretion. From 2936 patients, 2806 had baseline documentation and a follow-up of at least 12 months. Percentage of diagnoses were: nAMD 61.8%, DME 18.9%; BRVO 9.8%; CRVO 7.5% and mCNV 1.6%. After enrollment of treatment-naïve and pre-treated mCNV patients the observational period for each patient is intended to be 24 months.

Results: Within the subgroup of 41 German mCNV-patients 63.4% were female and the average age was 60 ± 14.2 years. 34% of patients were treated within German IVOM contracts. 22 patients (53.7%) of the population were already pretreated with ranibizumab, of which 5 patients were pretreated with other intravitreal anti-VEGF medication than ranibizumab, PDT or laser, as well. Mean refraction at baseline was 6.48 ± 6.37 dpt of spherical equivalent and -1.19 ± 0.84 dpt of cylindrical equivalent. Mean axial length at baseline was 29.57 ± 2.59 mm. Best corrected visual acuity (BCVA) at baseline was 58.8 ± 17.8 letters. At baseline, 73.2% of patients had OCT imaging, 51.2% of patients had fluorescein angiography (FA). The time between first visual acuity visit and first injection was 10.5 ± 14.4 days mean [median, 4 days]. Mean visual gain after 12 month observational period was 7.5 (± 11.5 letters) of which 22% responded with a gain equal or more than 15 letters.

Conclusion: PACIFIC provides real-life data for CNV therapy with ranibizumab. Observing local routine clinical practice may obtain a better understanding of how patients are treated in real life settings. Regarding the entire group of 41 naïve and pretreated patients favorable effects of ranibizumab on the visual acuity of mCNV patients were detected after 12 months in an interim analysis of the real-life PACIFIC study.