Donati, Simone http://orcid.org/0000-0002-6920-7021
Yang, Chang-Hao
Xu, Xun http://orcid.org/0000-0002-4246-4343
Mura, Marco http://orcid.org/0000-0001-5283-5366
Giocanti-Aurégan, Audrey http://orcid.org/0000-0002-7918-7845
Hoerauf, Hans
Allmeier, Helmut http://orcid.org/0000-0002-5165-4851
Machewitz, Tobias
Johnson, Kristian T.
Santoro, Elina
,
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
:
: Simone Donati declares that he has no competing interests. Chang-Hao Yang has received consulting fees and grants from Allergan, Bayer, and Novartis. Xun Xu declares that he has no competing interests. Marco Mura declares that he has no competing interests. Audrey Giocanti-Aurégan has acted as a clinical investigator for Bayer and received consulting fees from AbbVie, Alcon, Bayer, Novartis, Roche, and Théa. 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. Tobias Machewitz is an employee of Bayer AG, Berlin, Germany. Kristian T. Johnson is an employee of Bayer U.S. LLC, Cambridge, MA, USA. Elina Santoro has received consulting fees and grants from Alcon, 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. The applicable EMA guidelines and local laws and regulations in each country were adhered to. 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 the International Council for Harmonisation Guideline E3: Good Clinical Practice were also followed wherever possible. In each country where required, the protocol and any amendments thereof were reviewed and approved by the independent ethics committee or institutional review board of each study site. All patients provided written informed consent for participation in this study.