Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study

Ethical approval

The OCEAN study was approved by the ethics committee of the Eberhard-Karls-University, Tuebingen, Germany. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Separate informed consent was required for patients to be included in the ORCA module.

Consent to participate

Every patient was informed by the treating physician about the key objectives as well as the type and scope of the documentation. Eligible patients could only be included in the study after providing written informed consent, or, if incapable of doing so, after such consent had been provided by a legally acceptable representative of the patient.

Consent for publication

Patients signed informed consent regarding publishing their data.

Conflicts of interests

Georg Spital received personal fees from Bayer Healthcare, Novartis, Roche, OD-OS, and Allergan Pharma and grants from Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope, Alexion.

Steffen Schmitz-Valckenberg received contracts and personal fees for consultancy from Novartis as part of the submitted work. Outside the submitted work, he received grants or contracts from AlphaRET, Apellis, Bayer, Bioeq/Formycon, Carl Zeiss MediTec, Katairo, Kubota Vision, Novartis, Pixium, Roche/Genentech, SparingVision; Consulting fees from Apellis, Bioeq/Formycon, Galimedix, Novartis, Oxurion, Roche/Genentech; and nonfinancial support from Carl Zeiss Meditec and Heidelberg Engineering, outside the submitted work; being co-founder of the STZ GRADE Reading Centre.

Bettina Müller and Erika Liczenczias are employees of Novartis.

Petrus Chang received grants from Heidelberg Engineering, Novartis, ZeissMeditec.

Britta Heimes-Bussmann received grants Amgen, Iveric Bio, Roche, Kodiak, Novartis, Novo-Nordisk, Gyroscope and personal fees von Bayer.

Focke Ziemssen received research grants from Bayer, BMBF, Clearside, DFG, Kodiak, Iveric, Ophtea, Novartis, Regeneron, consulting fees from Alimera Sciences, Allergan/Abbvie, Bayer, Boehringer-Ingelheim, Novartis, NovoNordisk, MSD, Oxurion, Roche/Genentech, and fees as speaker from Alimera, Allergan/Abbvie, Bayer, BDI, CME Health, Gerling, Novartis, ODOS, Roche.

Sandra Liakopoulos received grants from Novartis, personal fees from Novartis, Heidelberg Engineering, Carl Zeiss Meditec, Allergan/Abbvie, Bayer, Apellis, and consulting fees from Novartis, Bayer, Apellis and Allergan.

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