title: A randomized clinical trial of intravitreal bevacizumab versus intravitreal dexamethasone for diabetic macular edema: the BEVORDEX study.
abstract: OBJECTIVE
  To report the 12-month results of the first head-to-head comparison of a dexamethasone implant (Ozurdex; Allergan, Inc., Irvine, CA) versus bevacizumab (Avastin; Genentech, South San Francisco, CA) for center-involving diabetic macular edema (DME).
  
  
  METHODS
  Phase 2, prospective, multicenter, randomized, single-masked clinical trial (clinicaltrials.gov identifier NCT01298076).
  
  
  METHODS
  We enrolled 88 eyes of 61 patients with center-involving DME.
  
  
  METHODS
  Forty-two eyes were randomized to receive bevacizumab every 4 weeks and 46 eyes were randomized to receive a dexamethasone implant every 16 weeks, both pro re nata. Results were analyzed using linear regression with generalized estimation equation methods to account for between-eye correlation.
  
  
  METHODS
  The primary outcome was the proportion of eyes that improved vision by 10 logarithm of minimum angle of resolution letters. Secondary outcomes included mean change in best-corrected visual acuity (BCVA), change in central macular thickness (CMT), injection frequency, and adverse events. Patient-reported outcomes were measured using the Impact of Vision Impairment (IVI) questionnaire.
  
  
  RESULTS
  Improvement in BCVA of 10 or more letters was found in 17 of 42 eyes (40%) treated with bevacizumab compared with 19 of 46 dexamethasone implant-treated eyes (41%; P = 0.83). None of the 42 bevacizumab eyes lost 10 letters or more, whereas 5 of 46 (11%) dexamethasone implant eyes did, mostly because of cataract. Mean CMT decreased by 122 μm for bevacizumab eyes and by 187 μm for dexamethasone implant eyes (P = 0.015). Bevacizumab-treated eyes received a mean of 8.6 injections compared with 2.7 injections for dexamethasone implant eyes. Significant improvement in IVI scores occurred for both treatment groups.
  
  
  CONCLUSIONS
  Dexamethasone implant achieved similar rates of visual acuity improvement compared with bevacizumab for DME, with superior anatomic outcomes and fewer injections. Both treatments were associated with improvement in visual quality-of-life scores. However, more dexamethasone implant-treated eyes lost vision, mainly because of cataract.
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Gillies
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Hospital, East Melbourne, Victoria, Australia.
authors.forename: Lyndell L
authors.initials: LL
authors.lastname: Lim
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Campain
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Godfrey J
authors.initials: GJ
authors.lastname: Quin
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Wedad
authors.initials: W
authors.lastname: Salem
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Ji
authors.initials: J
authors.lastname: Li
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Goodwin
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia.
authors.forename: Christine
authors.initials: C
authors.lastname: Aroney
authors.affiliation: Lions Eye Institute, Centre for Ophthalmology and Visual Science, University of Western Australia, Australia.
authors.forename: Ian L
authors.initials: IL
authors.lastname: McAllister
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, The University of Sydney, Sydney NSW, Australia. Electronic address: sfraserbell@gmail.com.
authors.forename: Samantha
authors.initials: S
authors.lastname: Fraser-Bell
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000068258:Bevacizumab; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000503:physiopathology; D004343:Drug Implants; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008266:Macula Lutea / Q000473:pathology; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012044:Regression Analysis; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D003692:Delayed-Action Preparations; D004343:Drug Implants; D000068258:Bevacizumab; D003907:Dexamethasone