Session Title: Imaging III
Session Date/Time: Saturday 13/09/2014 | 14:30-16:00
Paper Time: 15:02
Venue: Boulevard C
First Author: : S.Schmitz-Valckenberg GERMANY
Co Author(s): : S. Liakopoulos G. Spital F. Ziemssen A. Wiedon F.G. Holz
In Germany, guidelines recommend the regular use of SD-OCT imaging for monitoring patients with neovascular AMD (nAMD), diabetic macular edema (DME) and macular edema due to retinal vein occlusions (RVO). This underscores the role and increased importance of this imaging technique. The ORCA study aims to evaluate the status of real life SD-OCT image analysis by ophthalmologists in Germany compared with standardized analysis by specialized reading centers. This presentation will report first interim results.
ORCA is implemented as a substudy of the non-interventional OCEAN study. ORCA aims to observe up to 1.000 patients at 150 sites up to 24 months. All patients are diagnosed either with nAMD, visual impairment due to DME or RVO and treated with anti-VEGF-therapy (Ranibizumab) according to the investigators assessment.
ORCA investigators perform SD-OCT imaging for diagnosis and follow-up of their patients according to routine medical practice. The physicians then document their findings of the SD-OCT analysis in a pre-specified ORCA questionnaire and electronically submit the corresponding original SD-OCT images to the participating reading centers (CIRCL, GRADE, M3). The reading centers independently analyze the same SD-OCT images according to the same ORCA questionnaire to allow for a direct comparison. Color fundus photography and fluorescein angiography images are additionally collected at baseline and close-out visit. As primary endpoint of the analysis, ORCA will report the comparison between participating physicians and the reading centers in the recognition of at least one SD-OCT activity criteria as defined by the German ophthalmologic societies that requires anti-VEGF treatment.
German ophthalmologic societies recommend SD-OCT based (re-)treatment criteria for nAMD, DME and RVO. Nevertheless, many ophthalmologists feel uncertain about the SD-OCT settings and evaluating SD-OCT structures. For ORCA, the three reading centers GRADE (Bonn), CIRCL (Cologne) and M3 Makula Monitor Münster (Münster) developed in close cooperation a standardized grading protocol for each SD-OCT treatment, re-treatment or withdrawal criteria for SD-OCT. Reading Center grading results according to this protocol are compared to the status of real life SD-OCT image analysis in Germany. To date, there are almost 1.000 visits of 265 patients reported in ORCA. 63% of the patients are diagnosed with nAMD, 25% with DME and 12% with macular edema due to RVO. At EURETINA we will be able to present latest baseline data of the ORCA study delivered by the upcoming interim analysis in August 2014 including the agreement between physicians and reading centers regarding diagnosis and signs for disease activity on SD-OCT at baseline.
Today uncertainties are noted regarding SD-OCT image interpretation and (re-) treatment decisions in patients with neovascular and exudative macular diseases in part because of rapidly evolving OCT-technologies as well as treatment options. ORCA analyzes the status of SD-OCT image interpretation and (re-)treatment decision in real-life conditions compared to results by certified reading center graders using a standardized grading protocol. Inaccurate SD-OCT image interpretation may lead to under- or over-treatment of patients. The identification of specific features causing these difficulties may allow providing targeted training and optimizing treatment outcomes.