Abstract
The ORCA module of the non-interventional OCEAN study investigated the use of retinal imaging diagnostics in the clinical treatment of patients undergoing vascular endothelial growth factor (VEGF) inhibitor treatment as part of routine clinical care. This article analyzes the agreement between the diagnosis documented by the treating ophthalmologist and the evaluation of reading centers at baseline as well as the effect on the response to treatment during the course. Atotal of 396 patients (age 75.4years) were enrolled in which ranibizumab treatment was indicated by the treating ophthalmologist due to either diabetic macular edema (DME), neovascular age-related macular degeneration (nvAMD) or retinal venous occlusion (RVO). Over aperiod of 24months, patient and examination data, treatments and interpretation of retinal imaging data by the treating ophthalmologist were systematically recorded. Furthermore, retinal imaging data were also evaluated by three reading centers. In 338 out of 396 (85.4%) study eyes, the baseline diagnosis of the treating ophthalmologist was confirmed by the reading centers (DME 87.5%, nvAMD 82.3%, RVO 94.9%). In 17 of the remaining 58eyes with a discrepant diagnosis, there was at least a consensus with respect to the indications for VEGF inhibitor therapy. The differential diagnoses included avariety of different retinal diseases. During follow-up of up to 3 months, eyes with aconsistent diagnosis showed aclear increase in visual acuity (6.4 versus 2.7letters, p = 0.05) and greater decrease in central retinal thickness (-112.3 versus -24.4 μm, p < 0.0001). The initial treatment decision for anti-VEGF therapy with consideration of the differential diagnoses can be challenging. Accurate evaluation of the clinical and imaging findings along with appropriate expertise appear to be important. The observation of superior initial response in eyes with aconsensus of the diagnosis at baseline underlines the relevance of an adequate initial assessment for asuccessful treatment outcome.
Highlights
The ORCA module of the noninterventional OCEAN study investigated the use of retinal imaging diagnostics in the clinical treatment
This article analyzes the agreement between the diagnosis documented by the treating ophthalmologist
in which ranibizumab treatment was indicated by the treating ophthalmologist
Summary
DR diabetische Retinopathie, MÖ Makulaödem, CNV choroidale Neovaskularisation (CNV), ICCS idiopathische Chorioretinopathia centralis serosa, MacTel makuläre Teleangiektasien, MD Makuladegeneration aKeine AMD-typischen Veränderungen der äußeren Netzhautbanden in der OCT oder in der Enface-Bildgebung Eine Richtlinie mit Aufnahmeprotokoll und Beispielbildern wurde den Zentren zur Verfügung gestellt, ohne eine personenbezogene Zertifizierung mit Einreichung von Testbildern einzufordern. Das Kernstück des ORCA-Moduls war ein speziell entwickelter Fragebogen zur Auswertung der Bildgebungsbefunde zum Zeitpunkt der Indikationsstellung (Basisvisite) sowie der anschließenden Studienvisiten im Verlauf (Folgevisiten), um die ärztliche Qualität der Bildinterpretation zu evaluieren. Dieser Fragebogen wurde unabhängig sowohl vom jeweiligen Studienzentrum als auch von den Reading Centern für jede Visite beantwortet. Die Auswertung der Reading Center umfasste dabei die Bewertung durch 2 unabhängige und jeweils zertifizierte ärztliche Reader von je 2 unterschiedlichen Reading Centern mit anschließender Überprüfung und ggf. Im Rahmen der Basisvisite wurde zusätzlich bei den Reading Centern auch erhoben, welche der 3 Indikationen Bei NichtÜbereinstimmung mit wenigstens einer der 3 Indikationen musste eine mögliche Differenzialdiagnose von den Reading Centern angegeben und auch bestimmt werden, ob eine Indikation zur VEGF-.
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