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Josep Callizo, Thomas Bertelmann, Jessica Voegeler, Steffen Schmitz-Valckenberg, Georg Spital, Nicolas Feltgen, Sandra Liakopoulos, Focke Ziemssen; Real-life effectiveness of Ranibizumab in RVO patients in a prospective, non-interventional trial over 12 months (OCEAN study). Invest. Ophthalmol. Vis. Sci. 2017;58(8):3674.
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The non-interventional OCEAN trial recruited retinal vein occlusion (RVO) patients in order to collect prospective data in a real-life setting. Randomized controlled trials (RCTs) have proven the beneficial effect of vascular endothelial growth factor (VEGF) inhibition with Ranibizumab in several indications including central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). Analysis of this study will allow a better understanding of relevant hurdles and barriers as well as the role of OCT imaging under Ranibizumab treatment.
In the non-interventional, prospective OCEAN study (NCT02194803) 5.779 patients were observed over 24 months. Herein we report the 12-month interim analysis of 744 patients diagnosed with RVO (52% female/ 48% male) with an average age of 70.9 years. The following data were recorded and analyzed: number of visits, visual acuity, number of injections, the use of diagnostic tools (OCT, fluorescein angiography) and adverse events.
RVO patients received an average of 4.7 injections during the first year, while undergoing an average of 9.8 BCVA assessments and 4.3 OCT examinations. The average gain in BCVA was 12.3 ETDRS letters at 12 months. Moreover, 148 treatment-naive BRVO patients even gained on average 15.1 ETDRS letters and 87 treatment-naive CRVO gained on average 9.1 letters.When more than 6 OCTs were performed within the first year, a higher number of patients gained ≥ 5 letters (63.6%, n=117) in comparison with patients with one or none OCT examination (50.3%, n=102). The mean decrease in central retinal thickness was 166 µm. No new safety signals were identified. An update of 24-month data will be presented.
A 12-month observational period of the OCEAN trial clearly shows beneficial effects of Ranibizumab on BRVO and CRVO patients. The presented results indicate that the underutilization of diagnostic capabilities might accompany a possible undertreatment. Higher rates of OCT examinations were associated with better VA outcomes in RVO patients. This observation underlines the importance of additional measures improving adherence to and persistence of anti-VEGF treatment.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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