Session Title: Free Paper Session 7: Vascular Diseases & Diabetic Retinopathy II
Session Date/Time: Thursday 07/09/2017 | 14:30-16:00
Paper Time: 14:54
Venue: Room 117
First Author: : N.Feltgen GERMANY
Co Author(s): : F. Ziemssen G. Spital S. Liakopoulos J. Voegeler M. Koch S. Schmitz-Valckenberg
Randomized controlled trials (RCTs) have demonstrated a beneficial effect of ranibizumab in several indications including retinal vein occlusion (RVO). The non-interventional OCEAN trial was initiated to obtain prospective real-life data on RVO patients treated by vascular endothelial growth factor (VEGF) inhibition with ranibizumab. This study’s analysis will allow for deeper understanding of the influence of baseline factors on the patients’ adherence on anti-VEGF treatment in the real world.
Patients treatment was monitored under real-life conditions in this study in accordance with the tenets of the Declaration of Helsinki (NCT02194803). All treatments including diagnoses and monitoring were documented during the principal investigator’s routine practice and assessments. There was no mandatory treatment protocol.
Herein we report the results of the 12-month interim analysis of the non-interventional, prospective OCEAN study. 5.779 patients are observed in a prospective manner over 24 months with 744 patients being diagnosed with RVO. To assess the baseline factors and outcome of RVO patients, we have recorded and analyzed demographic data, number of visits, number of injections, best-corrected visual acuity (BCVA) assessments (converted to Early Treatment Diabetic Retinopathy Study [ETDRS] letters), the use of diagnostic tools (Optical coherence tomography (OCT), fluorescein angiography (FA)) and the occurrence of adverse events.
The OCEAN trial has enrolled 744 RVO patients with an average age of 70.9 years with more than 25% being younger than 65 representing the working age patient group. During the first year, RVO patients received an average of 9.8±3.6 BCVA assessments and 4.7±2.41 injections. In 89.7 % of the follow-up visits in the first year, a BCVA examination of the study eye was documented. The average time between consecutive BCVA examinations was 32.4±14.9 to 45.3±23.3 days. Patients with a baseline BCVA < 50 letters (n=225) were treated with 4.74±2.51 injections and could gain 21.9±28.3 letters, whereas patients with 50-65 letters (N=220) received 4.77±2.32 injections gained 12.0±14.2 letters and patients with a baseline BCVA >65 letters (n=289) had 4.70±2.40 injections gaining 2.1±12.4 letters. Overall RVO patients showed an 11.0±20.3 letter improvement at month 12. Treatment-naive branch RVO patients (N=148) gained 15.0±19.9 ETDRS letters and treatment-naive central RVO (N=87) gained 6.1±24.2 letters. No new safety signals were identified. An update of 24-month data will be presented at the congress.
In the non-interventional OCEAN trial we could show that differences in baseline visual acuity has a strong influence on the BCVA gains that are achieved in a real-life setting in RVO patients treated with ranibizumab. In general the injection rates were low compared to RCTs which might lead to potential undertreatment of patients. Nevertheless, the non-observational OCEAN trial found that in a real-life setting ranibizumab leads to beneficial effects on visual acuity in RVO patients with a safety profile similar to that observed in RCTs.