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Non-interventional trial to observe Lucentis? treatment patterns in real-life conditions: results of the first 1,000 patients finishing 12 months of observation period - Ocean study

Session Details

Session Title: Quick Fire Free Paper Session 01

Session Date/Time: Thursday 26/09/2013 | 08:30-10:30

Paper Time: 08:45

Venue: Hall G1 (Level 2)

First Author: F.Ziemssen GERMANY

Co Author(s):    A. Wiedon   G. Spital   S. Schmitz-Valckenberg   S. Scheidl     

Abstract Details

Purpose:

The OCEAN study evaluates Lucentis® treatment patterns in real-life conditions for all approved indications. It is not only important, whether, but why routine patient treatment does not meet the impressing endpoints of controlled clinical trials. The OCEAN study with 3.000 patients is the largest and highly representative non-interventional ophthalmologic trial in Germany so far. Beside new data for wet age-related macular degeneration (wAMD) OCEAN will generate first real-life data for the treatment of patients with visual impairment due to diabetic macular edema (DME) as well for patients with visual impairment due to macular edema following retinal vein occlusion (RVO).

Setting:

To evaluate Lucentis® treatment patterns in real-life conditions the trial was conducted as non-interventional study. Therefore, 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.

Methods:

The OCEAN study observes up to 3.000 patients treated with Lucentis® in all approved indications (wAMD, DME, RVO). 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, possible 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.

Results:

To date 2.623 patients are enrolled in OCEAN by 313 active sites. Out of these, 67,4% (1.796) are wAMD patients, 19,6% (515) DME patients and 12,9% (339) patients with RVO. For these patients 10.073 visits are reported and documented so far. At baseline, 70,7% of all patients were controlled with OCT. This proportion declined to 17,9% at month 1 and 22,1% at month 2. At month 3 the number of patients examined with OCT diagnostic was 42,2% and staid consistent at a similar level for further visits. Around 20% of the patients were referred for OCT diagnostic to clinics or resident colleagues. The VFQ-25 quality of life questionnaires were completed by 90% of the patients at baseline and by 87,8% at month 4. In August 2013 the first 1.000 OCEAN patients will have completed the first 12 months of the observation period. At EURETINA we will be able to further present time course of visual acuity, central retinal thickness, number of injections as well as number of visits for these patients.

Conclusions:

Although the German scientific ophthalmologic societies recommend monthly monitoring visits in combination with regular OCT examinations, the lower rate of follow-up examinations might have impact on the PRN treatment based on morphologic criteria. Presenting important real-life data for the treatment with Lucentis® in all approved indications, the OCEAN study observes the frequency of monitoring visits as well as the use of OCT in routine treatment in relation to the development of visual acuity and central retinal thickness. These data allow for a better understanding of the significant hurdles and efforts in the treatment of our patients.

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