Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naïve patients with neovascular age-related macular degeneration.

"Declarations Ethics approvalNo Independent Ethics Committee or Institutional Review Board approval was obtained because of the study’s observational design in accordance with the requirements of local law and regulations in France. The protocol was reviewed and approved by a French data privacy committee: Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé (CCTIRS) and Commission Nationale de l’Informatique et des Libertés (CNIL). Bayer France received a positive statement from the CCTIRS on June 18, 2014, and an authorization from the CNIL on October 14, 2014, for the RAINBOW study. All patients provided written informed consent for participation in this study. Consent for publicationNot applicable. Competing interestsSYC: consulting fees from Allergan, Bayer, Novartis, Roche, and Théa; CF: consulting fees from Allergan, Bayer, and Novartis; SB: consulting fees from Bayer, Allergan/AbbVie, Horus Pharma, Novartis, and Roche; HO: consulting fees from Allergan, Bayer, Novartis, Roche, and Théa; LK: consulting fees from Allergan/AbbVie, Alcon, Bayer, Krystal Biotech, Novartis, Regeneron, and Théa; MW: member of the French advisory board for Bayer. MD and FC declare no competing interests. Competing interests SYC: consulting fees from Allergan, Bayer, Novartis, Roche, and Théa; CF: consulting fees from Allergan, Bayer, and Novartis; SB: consulting fees from Bayer, Allergan/AbbVie, Horus Pharma, Novartis, and Roche; HO: consulting fees from Allergan, Bayer, Novartis, Roche, and Théa; LK: consulting fees from Allergan/AbbVie, Alcon, Bayer, Krystal Biotech, Novartis, Regeneron, and Théa; MW: member of the French advisory board for Bayer. MD and FC declare no competing interests."

"Funding The RAINBOW study was sponsored by Bayer HealthCare S.A.S., Loos, France. The journal’s open access fee was funded by Bayer Consumer Care AG, Basel, Switzerland."

"Trial registration number ClinicalTrials.gov Identifier: NCT02279537."