Session Title: Free Paper Session 2: Vascular Diseases & Diabetic Retinopathy I
Session Date/Time: Thursday 07/09/2017 | 09:00-10:30
Paper Time: 09:30
Venue: Room 117
First Author: : L.Kuehlewein GERMANY
Co Author(s): : M. Koch J. Voegeler T. Bertelmann S. Schmitz-Valckenberg S. Liakopoulos G. Spital
There is limited prospective data for diabetic macula edema (DME) patients treated with ranibizumab, an anti-vascular endothelial growth factor (VEGF), in a real-life setting. The OCEAN trial (NCT02194803) was designed to examine how the outcomes in DME patients treated with ranibizumab in a real-life setting compares with those seen in randomized controlled trials. Aim of the current analysis was to evaluate in detail the management of the subgroup of DME patients in the OCEAN-study.
Treatment patterns under real-life conditions were monitored in this prospective non-interventional study in accordance with the tenets of the Declaration of Helsinki (NCT02194803). All treatments including diagnoses and monitoring were documented as part of the routine practice management and the assessment of the investigator. There was no mandatory treatment protocol.
5,779 patients were observed and documented in the non-interventional, prospective OCEAN study in a prospective manner over 24 months. In this 12-month interim analysis 1217 patients, diagnosed with DME, were analyzed by their number of visits and injections, their best-corrected visual acuity (BCVA), the use of diagnostic tools like optical coherence tomography (OCT) imaging, and the occurrence of adverse events.
1.217 DME patients with an average age of 67.6 years had a mean of 9.6 ± 3.8 BCVA assessments and 3.9 ± 3.5 OCT examinations during the first year. With a mean of 4.4 ± 2.29 injections, the baseline BCVA of 60.6 ETDRS letters increased to 64.9 ± 19.5 letters after 12 months (a gain of 4.3 ± 15.2 letters). 40.67% patients gained at least five letters, while 18.32% patients gained 15 or more letters. A time-to-response analysis showed that patients receiving at least 7 injections reached the 15-letter threshold earlier (mean of 420.3 days) compared to patients receiving only 1-3 (mean of 484.1 days) or 3-6 injections (mean of 430.7 days). Furthermore, patients in this subgroup, receiving seven or more injections, gained 6.1 letters after the twelve months observation period. A gain of at least 10 letters or more was reached by 23.53% of patients when no or only 1 OCT for disease monitoring was done compared to 35.74% patients reaching this level, when four to six 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.
The 12 months interim analysis of the real-life OCEAN trial shows favorable outcome on the visual acuity of DME patients. Higher number of OCT evaluations and injections were associated with better visual acuity gains. A time-to-response analysis shows clearly that patients treated with a higher number of injections show an earlier response to ranibizumab treatment. These findings underscore the importance of close monitoring including OCT examination and an intensive treatment of ranibizumab in DME patients.