Session Title: FP-15 Vascular Diseases and Diabetic Retinopathy V
Session Date/Time: Sunday 14/09/2014 | 08:00-10:00
Paper Time: 08:16
Venue: Boulevard D
First Author: : F.Ziemssen GERMANY
Co Author(s): : S. Liakopoulos S. Schmitz-Valckenberg G. Spital A. Wiedon F. Holz
OCEAN evaluates Ranibizumab treatment patterns in real-life conditions for all approved indications. Real-life monitoring is of increasing importance for various reasons including recently observed less favourable outcomes when compared to prospective, controlled clinical trials. The OCEAN study with 4,500 patients is the largest German non-interventional ophthalmological trial in this respect. Besides new data for wet age-related macular degeneration (wAMD), OCEAN will generate first multi-center real-life data for the treatment of patients with diabetic macular edema (DME), macular edema due to retinal vein occlusion (RVO) and choroidal neovascularization secondary to pathologic myopia (mCNV).
To evaluate Ranibizumab treatment patterns in real-life conditions the trial is conducted as non-interventional study. All treatments including diagnoses and monitoring are performed according to routine praxis management and the assessment of the investigator. There is no mandatory treatment protocol.
The OCEAN study observes up to 4.500 patients treated with Ranibizumab in all approved indications. Patients who received anti-VEGF treatment in the last three months prior to enrollment or any steroid treatment are not included in the study. The observation period is 24 months. During this time the following data is recorded: number of visits, visual acuity, number of injections, use of diagnostic tools (OCT, FLA), central retinal thickness, laser treatment, concomitant medication and others. Changes in patient related quality of life are assessed via VFQ-25 at baseline, months 4, 12 and 24.
To date 4344 patients are enrolled in OCEAN by 373 active sites. Out of these, 64.8% (2,815) are wAMD patients, 20.6% (897) DME patients, 13.0% (564) RVO patients and 0.3% (13) patients with mCNV. According to the last interim analysis in August 2013 the study population is composed as follows: 63% of the wAMD patients are female while the gender distribution for the indications DME and RVO is balanced (49% female). DME patients represent the youngest patient population with a mean age of 67.8 years compared to a mean age of 78.0 years for wAMD patients and 71.5 years for RVO patients. 80.6% of the wAMD patients, 91.6% of the DME patients and 95.6% of the RVO patients were recorded as Lucentis®-naïve. On average, the median time from the first visual acuity assessment to the first Lucentis® treatment in OCEAN was 15 days for wAMD patients, 22 days for DME patients and 17 days for RVO patients. At EURETINA we will present the latest baseline and outcome data of the interim analysis coming up in August 2014 with approximately 2,000 wAMD patients, 700 DME patients and 450 RVO patients who will have completed 12 months of the OCEAN observation period.
Following the initial monthly intravitreal injections, the guidelines in Germany recommend a PRN treatment regimen with monthly monitoring visits and regular OCT examinations. The OCEAN study systematically records the frequency of monitoring visits, the use of OCT in routine treatment as well as the number of injections, visual acuity and central retinal thickness. Therefore, the OCEAN study is an important source of real-life data for the treatment of wAMD, DME, RVO and mCNV patients with Ranibizumab in Germany. The data will provide information of the actual patient care situation and may allow for a better understanding of relevant hurdles and barriers to optimal treatment and outcome.