title: A Retrospective Study of Ranibizumab Treatment Regimens for Neovascular Age-Related Macular Degeneration (nAMD) in Australia and the United Kingdom.
abstract: Neovascular age-related macular degeneration (nAMD) is the leading cause of vision loss among persons aged 65 years and older. Anti-vascular endothelial growth factor (anti-VEGF) treatment is the recommended standard of care. The current study compares the effectiveness of ranibizumab in routine clinical practice in two countries that generally apply two different treatment regimens, treat-and-extend (T&E) in Australia or pro re nata (PRN) in the UK.
  
  
  
  This retrospective, comparative, non-randomised cohort study is based on patients' data from electronic medical record (EMR) databases in Australia and the UK. Treatment regimens were defined based on location, with Australia as a proxy for analysing T&E and UK as a proxy for analysing PRN. The study included patients with a diagnosis of nAMD who started treatment with ranibizumab between January 2009 and July 2014. A total of 647 eyes of 570 patients in Australia and 3187 eyes of 2755 patients in the UK with complete 12-months follow-up were analysed.
  
  
  
  Baseline patient characteristics were comparable between the two cohorts. After 1 year of treatment, T&E-treated eyes achieved higher mean (±SE) visual acuity (VA) gains (5.00 ± 0.54 letters [95% confidence interval (CI) 3.93-6.06]) than PRN-treated eyes [3.04 ± 0.24 letters (95% CI 2.57-3.51); difference in means 2.07 ± 0.69 (95% CI 0.73-3.41), p < 0.001]. Non-inferiority of T&E compared to PRN was concluded based on the change in mean visual acuity gains at 12 months. Over the 12-month follow-up, T&E-treated eyes received a higher mean [±standard deviation (SD)] number of injections (9.29 ± 2.43) than PRN-treated eyes (6.04 ± 2.19) (p < 0.0001). Australian patients had a lower mean (±SD) number of total clinic visits (10.29 ± 2.90) than UK patients (11.47 ± 2.93) (p < 0.0001).
  
  
  
  The higher injection frequency in the T&E cohort may account for the trend toward improved vision.
  
  
  
  Novartis Pharma AG, Basel, Switzerland.
authors.affiliation: The Royal College of Ophthalmologists' National Ophthalmology Database, London, UK.|Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Johnston
authors.affiliation: QuintilesIMS, Frankfurt am Main, Germany.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Carius
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Adrian
authors.initials: A
authors.lastname: Skelly
authors.affiliation: Novartis Pharma AG, Basel, Switzerland. alberto.ferreira@novartis.com.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ferreira
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Fran
authors.initials: F
authors.lastname: Milnes
authors.affiliation: Department of Ophthalmology, Westmead Millennium Institute, University of Sydney, Westmead, NSW, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Mitchell
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D001315:Australia / Q000453:epidemiology; D020256:Choroidal Neovascularization / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D016208:Databases, Factual; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000379:methods; D057286:Electronic Health Records / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D000069579:Ranibizumab / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*; D014792:Visual Acuity / Q000187:drug effects; D057135:Wet Macular Degeneration / Q000188:drug therapy / Q000453:epidemiology / Q000378:metabolism / Q000503:physiopathology
chemical_list: D020533:Angiogenesis Inhibitors; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: Anti-vascular endothelial growth factor; Neovascular age-related macular degeneration; Pro re nata regimen; Ranibizumab; Real-world data; Treat-and-extend regimen; Visual acuity