Giocanti-Aurégan, Audrey http://orcid.org/0000-0002-7918-7845
Donati, Simone http://orcid.org/0000-0002-6920-7021
Hoerauf, Hans
Allmeier, Helmut http://orcid.org/0000-0002-5165-4851
Rittenhouse, Kay D. http://orcid.org/0000-0001-7503-5759
Machewitz, Tobias
Yang, Chang-Hao
,
Clinical trials referenced in this document:
Documents that mention this clinical trial
Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study
https://doi.org/10.1007/s40123-023-00830-w
Funding for this research was provided by:
Pharmaceuticals Bayer
Article History
Received: 31 May 2023
Accepted: 29 September 2023
First Online: 4 November 2023
Declarations
:
: Audrey Giocanti-Aurégan has acted as a clinical investigator for Bayer and received consulting fees from AbbVie, Alcon, Bayer, Novartis, Roche, and Théa. Simone Donati declares that he has no competing interests. Hans Hoerauf has received consulting fees from AbbVie, Alcon, Allergan, Bayer, Heidelberg Engineering, Novartis, Oxurion, and Roche. Helmut Allmeier is an employee of Bayer Consumer Care AG, Basel, Switzerland. Kay D. Rittenhouse was a former employee of Bayer USA LLC, Whippany, NJ, United States, and is now retired. Tobias Machewitz is an employee of Bayer AG, Berlin, Germany. Chang-Hao Yang has received consulting fees and grants from Allergan, Bayer, and Novartis.
: No master Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approval was obtained as no participating study site was deemed to be the main center for the study. Appendix I in the Supplementary Materials lists the local IRB/IEC committee names and approval numbers in all participating countries where relevant under local law. The AURIGA study was an observational study in which IVT-AFL was prescribed in the customary manner in accordance with the terms of the marketing authorization. There was no assignment of patients to a particular therapeutic strategy. All treatment decisions fell within current practice, and the prescription of IVT-AFL was clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring evaluations were required for participation in the study. Epidemiological methods were used for the analysis of the collected data. The AURIGA study was conducted in accordance with the Helsinki Declaration of 1964 and the applicable EMA guidelines and local laws and regulations in each country. The recommendations of the European Federation of Pharmaceutical Industries and Associations (EFPIA), European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP), Good Pharmacovigilance Practices (GVP module VI), and International Council for Harmonization Guideline E3: Good Clinical Practice were also followed wherever possible. In all countries where required, the protocol and any amendments were reviewed and approved by each study site’s independent ethics committee or institutional review board before and during the study. All patients provided written informed consent for participation in this study.