title: Ranibizumab and bevacizumab for neovascular age-related macular degeneration.
abstract: BACKGROUND
  Clinical trials have established the efficacy of ranibizumab for the treatment of neovascular age-related macular degeneration (AMD). In addition, bevacizumab is used off-label to treat AMD, despite the absence of similar supporting data.
  
  
  METHODS
  In a multicenter, single-blind, noninferiority trial, we randomly assigned 1208 patients with neovascular AMD to receive intravitreal injections of ranibizumab or bevacizumab on either a monthly schedule or as needed with monthly evaluation. The primary outcome was the mean change in visual acuity at 1 year, with a noninferiority limit of 5 letters on the eye chart.
  
  
  RESULTS
  Bevacizumab administered monthly was equivalent to ranibizumab administered monthly, with 8.0 and 8.5 letters gained, respectively. Bevacizumab administered as needed was equivalent to ranibizumab as needed, with 5.9 and 6.8 letters gained, respectively. Ranibizumab as needed was equivalent to monthly ranibizumab, although the comparison between bevacizumab as needed and monthly bevacizumab was inconclusive. The mean decrease in central retinal thickness was greater in the ranibizumab-monthly group (196 μm) than in the other groups (152 to 168 μm, P=0.03 by analysis of variance). Rates of death, myocardial infarction, and stroke were similar for patients receiving either bevacizumab or ranibizumab (P>0.20). The proportion of patients with serious systemic adverse events (primarily hospitalizations) was higher with bevacizumab than with ranibizumab (24.1% vs. 19.0%; risk ratio, 1.29; 95% confidence interval, 1.01 to 1.66), with excess events broadly distributed in disease categories not identified in previous studies as areas of concern.
  
  
  CONCLUSIONS
  At 1 year, bevacizumab and ranibizumab had equivalent effects on visual acuity when administered according to the same schedule. Ranibizumab given as needed with monthly evaluation had effects on vision that were equivalent to those of ranibizumab administered monthly. Differences in rates of serious adverse events require further study. (Funded by the National Eye Institute; ClinicalTrials.gov number, NCT00593450.).
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Martin
authors.forename: Maureen G
authors.initials: MG
authors.lastname: Maguire
authors.forename: Gui-shuang
authors.initials: GS
authors.lastname: Ying
authors.forename: Juan E
authors.initials: JE
authors.lastname: Grunwald
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Fine
authors.forename: Glenn J
authors.initials: GJ
authors.lastname: Jaffe
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D002318:Cardiovascular Diseases / Q000453:epidemiology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008268:Macular Degeneration / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D016016:Proportional Hazards Models; D000069579:Ranibizumab; D012160:Retina / Q000187:drug effects / Q000473:pathology; D016037:Single-Blind Method; D013810:Therapeutic Equivalency; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000069579:Ranibizumab