Session Title: Imaging I
Session Date/Time: Friday 18/09/2015 | 08:00-09:30
Paper Time: 08:40
First Author: : S.SchmitzValckenberg GERMANY
Co Author(s): : S. Liakopoulos G. Spital F. Ziemssen T. Knorr F. Holz
PURPOSE:Morphologic alterations of the retina typically precede functional impairment and, therefore, represent a better tool for assessing re-treatment criteria in patients undergoing treatment with VEGF (vascular endothelial growth factor)-inhibitors. However, clear guidelines and standards for interpreting often complex spectral-domain optical coherence tomography (SD-OCT) findings are lacking. ORCA analyzes the impact of SD-OCT-based re-treatment criteria and evaluates the status quo of real-life SD-OCT image analysis by ophthalmologists both in referral hospital and private practice in Germany through standardized analysis by reading centers. ORCA is implemented as a sub-study of the OCEAN trial, a large non-interventional study (NCT02194803).
Three reading centers (GRADE Reading Center Bonn, CIRCL Cologne Image Reading Center, and M3 Macula Monitor Münster) have developed and defined standardized imaging protocols and grading parameters for the management of anti-VEGF therapy in accordance with the guidelines published by German ophthalmological societies.
Patients diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO) undergoing treatment with Lucentis (ranibizumab) were included. SD-OCT imaging was performed at any timepoint at the discretion of the treating physician and according to a pre-specified imaging protocol. Analysis of imaging data was conducted using a pre-specified questionnaire by the treating physician and independently by the reading centers. To evaluate hemorrhages as well as to confirm the diagnosis of the patients, color fundus photography and fluorescein angiography images were additionally collected at baseline and close-out visits. Disease activity at baseline was defined as any intra- or subretinal fluid on SD-OCT. Both baseline demographics and accordance/discordance of SD-OCT parameters between treating physicians and the analysis by the reading centers was analyzed.
A total of 283 patients (mean age 75.5 years) enrolled by 28 active sites were available for analysis. According to the treating physician assessment, there were 175 (61.4%) patients with nAMD, 64 (22.6%) with DME, and 44 (15.6%) with RVO. Patients with nAMD were older (mean age 79.2 years) as compared to patients with DME (67.3 years) or RVO (72.6 years). The proportion of female patients was highest in nAMD (64.4%) followed by RVO (60.0%) and DME (56.0%). Best corrected visual acuity (BCVA (logMAR)) of the study eye at baseline was 0.411 in nAMD patients, 0.414 in DME patients, and 0.584 in RVO patients. Central subfield retinal thickness was 368.7 microns in nAMD, 380.3 microns in DME and 468.8 microns in RVO. The diagnosis made by the treating physician could be confirmed in 83.4% of the patients. The accordance rate of the reading centers and ophthalmologist for disease activity was 86.1% (“yes”: 91.6%; “no”: 34.4%) for nAMD patients and 90.7% (“yes”:94.2%; “no”: 47.6%) for RVO and DME (pooled) patients. 72.0% of the hospital-based physicians and 66.7% of the general ophthalmologists had ≥2 years’ experience in OCT diagnostics.
The real-life baseline data from the ORCA study represents a typical population of subjects undergoing anti-VEGF therapy. The results indicate that differential diagnosis prior to initiating anti-VEGF therapy may be challenging. While there appears to be a high agreement in detecting disease activity, the false-negative rate for identification of intra- and subretinal fluid was moderate, indicating that signs of disease activity may be overlooked by clinicians.