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Focke Ziemssen, Jessica Voegeler, Steffen Schmitz-Valckenberg, Georg Spital, Sandra Liakopoulos; Dependency of BCVA and ranibizumab treatment frequency of DME patients in a real-life setting (OCEAN study). Invest. Ophthalmol. Vis. Sci. 2017;58(8):1904.
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To date there are little prospective data investigating DME patients in a real-life setting. Randomized controlled trials have already proven the favourable effect of vascular endothelial growth factor (VEGF) inhibition with ranibizumab in several indications including diabetic macula edema (DME). In order to gain knowledge of the relevant hurdles and barriers and the impact of optical coherence tomography (OCT) diagnostic on the treatment with ranibizumab the OCEAN included a subgroup of DME patients.
In the non-interventional, prospective OCEAN study 5.779 patients are monitored in a prospective manner over 24 month (NCT02194803). The 12-month interim analysis of 1217 patients diagnosed with DME (57.44% female/42.07% male) with an average age of 67.6 years. The following data were recorded and analyzed: number of visits, best corrected visual acuity (BCVA), number of injections and the use of diagnostic tools and adverse events.
With an average of 4.4.injections, initial baseline BCVA of 60.6 ETDRS letters increased to 64.9 ± 19.5 letters after 12 months (a gain of 4.3 letters). Patients receiving 7 or more injections gained 6.1 letters. 40.67% patients gained ≥ 5 letters, while 27.77% patients gained ≥ 10 letters and 18.32% ≥ 15 letters. A time-to-response analysis showed that patients receiving at least 7 injections reached the 15-letter threshold earlier.Patients had an average of 9.6 BCVA assessments and 3.9 OCT examinations during the first year. A higher amount of patients achieved ≥ 10 letters, when more OCTs were taken for disease monitoring: 23.53% for one or less OCT, 35.74% when 4 to 6 OCT examinations were done. The safety profile of ranibizumab was consistent with previously reported DME studies with no new safety findings.An update of the final 24-months data will be presented.
Favorable effects of ranibizumab on visual acuity of DME patients are detected after 12 months in an interim analysis of the real-life OCEAN trial. This improvement was shown to be dependent on the number of injections. Furthermore there might be a relationship between the number of OCT-examinations and BCVA improvement. Our data shows that relevant BCVA gain is more likely to be achieved with sufficient treatment and follow-up in real-life setting.
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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