ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD)
Sandra Liakopoulos, Georg Spital, Christian K Brinkmann, Tina Schick, Focke Ziemssen, Jessica Voegeler, Mirja Koch, Bernd Kirchhof, Frank G Holz, Daniel Pauleikhoff, Steffen Schmitz-Valckenberg, Sandra Liakopoulos, Georg Spital, Christian K Brinkmann, Tina Schick, Focke Ziemssen, Jessica Voegeler, Mirja Koch, Bernd Kirchhof, Frank G Holz, Daniel Pauleikhoff, Steffen Schmitz-Valckenberg
Abstract
Background/aims: The prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD).
Methods: 2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated.
Results: CNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit.
Conclusion: Although broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required.
Trial registration number: NCT02194803.
Keywords: macula; neovascularisation; retina.
Conflict of interest statement
Competing interests: SL received personal fees from Novartis, Heidelberg Engineering, Carl Zeiss Meditec, Allergan, Bayer, and was member of an advisory board for Novartis. GS received personal fees from Bayer Healthcare, Novartis, Zeiss, OD-OS and Allergan Pharma. CKB has received grants from Heidelberg Engineering, Newtricious, Novartis, Zeiss Meditec; and personal fees from Heidelberg Engineering, Newtricious and Novartis. TS received personal fees from Novartis. FZ received grants and personal fees from Alimera, Allergan, Bayer Healthcare, Biogen and Roche, grants from Clearside, personal fees from Boehringer Ingelheim, Novartis, NovoNordisk and MSD Sharp & Dohme. JV and MK are employees of Novartis. BK received grants from Novartis and personal fees from Novartis, Pfizer and Bayer. FGH received grants from Acucela, Alcon, Allergan, Bayer, Genentech, Heidelberg Engineering, Novartis, Ophthotech, Roche and personal fees from Allergan, Bayer, Genentech, Novartis, Ophthotech; he was a member of advisory boards for Acucela, Allergan, Avalanche, Bayer, Genentech, Heidelberg Engineering, Johnson & Johnson, Novartis, Ophthotech and Roche. DP received grants from Novartis, Ophthotech, Acucela, Genentech, Roche, Bayer and personal fees from Novartis, Bayer, Allergan; he was a member of advisory boards for Novartis, Bayer and Allergan. SS-V received grants and non-financial research funding from Acucela, Alcon/Novartis, Allergan, Bayer, Bioeq/Formycon, Centervue, Galimedix, Genentech/Roche, Heidelberg Engineering, Optos, Carl Zeiss MediTec, and personal fees and honoraria from Alcon/Novartis, Bayer, Genentech/Roche and Carl Zeiss MediTec.
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
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