title: A prospective randomized trial of intravitreal bevacizumab or laser therapy in the management of diabetic macular edema (BOLT study) 12-month data: report 2.
abstract: OBJECTIVE
  To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).
  
  
  METHODS
  Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.
  
  
  METHODS
  A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.
  
  
  METHODS
  Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).
  
  
  METHODS
  The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.
  
  
  RESULTS
  The baseline mean ETDRS BCVA was 55.7+/-9.7 (range 34-69) in the bevacizumab group and 54.6+/-8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3+/-10.4 (range 34-79) in the bevacizumab group and 50.0+/-16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining > or =10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507+/-145 microm (range 281-900 microm) at baseline to 378+/-134 microm (range 167-699 microm) (P<0.001) in the ivB group, whereas it decreased to a lesser extent in the laser group, from 481+/-121 microm (range 279-844 microm) to 413+/-135 microm (range 170-708 microm) (P = 0.02). The median number of injections was 9 (interquartile range [IQR] 8-9) in the ivB group, and the median number of laser treatments was 3 (IQR 2-4) in the MLT group.
  
  
  CONCLUSIONS
  The study provides evidence to support the use of bevacizumab in patients with center-involving CSME without advanced macular ischemia.
authors.affiliation: Department of Medical Retina, Moorfields Eye Hospital, London, United Kingdom. michel.michaelides@ucl.ac.uk
authors.forename: Michel
authors.initials: M
authors.lastname: Michaelides
authors.forename: Andrew
authors.initials: A
authors.lastname: Kaines
authors.forename: Robin D
authors.initials: RD
authors.lastname: Hamilton
authors.forename: Samantha
authors.initials: S
authors.lastname: Fraser-Bell
authors.forename: Ranjan
authors.initials: R
authors.lastname: Rajendram
authors.forename: Fahd
authors.initials: F
authors.lastname: Quhill
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Boos
authors.forename: Wen
authors.initials: W
authors.lastname: Xing
authors.forename: Catherine
authors.initials: C
authors.lastname: Egan
authors.forename: Tunde
authors.initials: T
authors.lastname: Peto
authors.forename: Catey
authors.initials: C
authors.lastname: Bunce
authors.forename: R David
authors.initials: RD
authors.lastname: Leslie
authors.forename: Philip G
authors.initials: PG
authors.lastname: Hykin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019233:Retreatment; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body
chemical_list: D020533:Angiogenesis Inhibitors; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab