title: A treat and extend regimen using ranibizumab for neovascular age-related macular degeneration clinical and economic impact.
abstract: OBJECTIVE
  To evaluate the visual outcome, number of injections, and direct medical cost of a "treat and extend" regimen (TER) in managing neovascular age-related macular degeneration (nAMD) with intravitreal ranibizumab.
  
  
  METHODS
  Retrospective, interventional, consecutive case series.
  
  
  METHODS
  Ninety-two eyes of 92 patients met the entry criteria from May 2006 to May 2008.
  
  
  METHODS
  All patients with treatment-naïve nAMD were treated monthly until no intraretinal or subretinal fluid was observed on optical coherence tomography (OCT). The treatment intervals were then sequentially lengthened by 2 weeks until signs of exudation recurred. The interval was individualized for each patient in an attempt to maintain an exudation-free macula.
  
  
  METHODS
  Change from baseline visual acuity, proportion of eyes losing < 3 lines and gaining ≥ 3 lines at 1 year of follow-up, annual mean number of injections, change from baseline OCT central retinal thickness (CRT), maximum period of extension, and adverse ocular and systemic events.
  
  
  RESULTS
  The mean follow-up was 1.52 years. Mean Snellen visual acuity improved from 20/135 at baseline to 20/77 at 1 year follow-up (P < 0.001) and 20/83 at 2 years follow-up (P = 0.002). The proportion of eyes that lost < 3 Snellen visual acuity lines at final follow-up was 96% and the proportion that gained ≥ 3 Snellen visual acuity lines was 32%. The mean OCT CRT decreased from 303 μm at baseline to 238 μm at 1 year follow-up (P < 0.001). The mean number of injections over the first year and between years 1 and 2 was 8.36 and 7.45, respectively. The mean maximum period of extension was 79.9 days. No adverse ocular or systemic events were reported during the follow-up period. The direct annual medical cost per patient was $16,114.52 for the TER. The direct annual medical cost per patient ranged from $15,880.07 to $28,314.16 based on previous clinical trial protocols.
  
  
  CONCLUSIONS
  Eyes with nAMD experienced significant visual improvement when managed with intravitreal ranibizumab using a TER. This treatment approach also was associated with significantly fewer patient visits, injections, and direct annual medical cost compared with monthly injections such as in the phase III clinical trials.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Retina Service, Wills Eye Institute, Thomas Jefferson University, Philadelphia, Pennsylvania 19140, USA. ogupta@hotmail.com
authors.forename: Omesh P
authors.initials: OP
authors.lastname: Gupta
authors.forename: Gary
authors.initials: G
authors.lastname: Shienbaum
authors.forename: Avni H
authors.initials: AH
authors.lastname: Patel
authors.forename: Christopher
authors.initials: C
authors.lastname: Fecarotta
authors.forename: Richard S
authors.initials: RS
authors.lastname: Kaiser
authors.forename: Carl D
authors.initials: CD
authors.lastname: Regillo
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000191:economics*; D061067:Antibodies, Monoclonal, Humanized; D020256:Choroidal Neovascularization / Q000188:drug therapy / Q000191:economics* / Q000503:physiopathology; D017281:Cost of Illness; D004180:Direct Service Costs / Q000706:statistics & numerical data*; D016527:Drug Costs; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D008268:Macular Degeneration / Q000188:drug therapy / Q000191:economics* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D000069579:Ranibizumab; D019233:Retreatment; D012189:Retrospective Studies; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology*; D014822:Vitreous Body
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069579:Ranibizumab