title: A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.
abstract: OBJECTIVE
  The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice.
  
  
  METHODS
  The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion.
  
  
  RESULTS
  Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice.
  
  
  CONCLUSIONS
  This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified.
authors.affiliation: Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Freekje
authors.initials: F
authors.lastname: van Asten
authors.forename: Kim U
authors.initials: KU
authors.lastname: Evers-Birkenkamp
authors.forename: Janneke J C
authors.initials: JJ
authors.lastname: van Lith-Verhoeven
authors.forename: Yvonne
authors.initials: Y
authors.lastname: de Jong-Hesse
authors.forename: Vincent P T
authors.initials: VP
authors.lastname: Hoppenreijs
authors.forename: Richard F
authors.initials: RF
authors.lastname: Hommersom
authors.forename: Agnes M
authors.initials: AM
authors.lastname: Scholten
authors.forename: Carel B
authors.initials: CB
authors.lastname: Hoyng
authors.forename: Johannes H J
authors.initials: JH
authors.lastname: Klaver
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D000069579:Ranibizumab; D018434:Sickness Impact Profile; D011795:Surveys and Questionnaires; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014786:Vision Disorders / Q000517:prevention & control; D014792:Visual Acuity / Q000502:physiology; D057135:Wet Macular Degeneration / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000069579:Ranibizumab
keywords: daily practice; neovascular AMD; observational; quality of life; ranibizumab; visual acuity