title: Efficacy of dexamethasone versus bevacizumab on regression of hard exudates in diabetic maculopathy: data from the BEVORDEX randomised clinical trial.
abstract: OBJECTIVE
  To report the effect of bevacizumab versus dexamethasone on hard exudates (HEX) in diabetic macular oedema (DME).
  
  
  METHODS
  Post hoc analysis of 24-month data from the Randomised clinical trial of BEVacizumab OR DEXamethasone for diabetic macular oedema (BEVORDEX) phase 2 multicentre randomised clinical trial. Eyes with centre-involving DME resistant to or unlikely to benefit from macular laser therapy were included. Eyes were randomly assigned to bevacizumab every 4 weeks or Ozurdex dexamethasone implant (DEX) every 16 weeks, both as required. The 68 eyes from 48 patients that completed 24-month follow-up were analysed. Two masked graders assessed extent and location of HEX on baseline, 12-month and 24-month foveal-centred colour fundus photographs using validated grading software.
  
  
  RESULTS
  Macular HEX was present in 60% of study eyes. Of these, 21 eyes were treated with DEX and 20 eyes with bevacizumab. Both treatments led to reduction in area of macular HEX at 12 months and 24 months. There was greater regression of HEX from the foveal centre in DEX-treated eyes (median change +890 µm, IQR=1040 µm) than bevacizumab-treated eyes (median change +7.0 µm, IQR=590 µm) at 12 months (p=0.04) but the difference was no longer statistically significant (p=0.10) by 24 months (DEX +1400 µm, IQR=1590 µm; bevacizumab +20 µm, IQR=2680 µm). Reassuringly, no study eye developed HEX at the foveal centre, a visually devastating consequence of diabetic maculopathy.
  
  
  CONCLUSIONS
  Bevacizumab and DEX were effective in reducing area of HEX in eyes with DME. DEX provided more rapid regression of HEX from the foveal centre although bevacizumab-treated eyes started to catch up by 24 months. Distance from the foveal centre as well as total area of macular HEX should be assessed when evaluating treatments for foveal-threatening HEX.
  
  
  BACKGROUND
  NCT01298076; Post-results.
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.|National Institute for Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Hemal
authors.initials: H
authors.lastname: Mehta
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Samantha
authors.initials: S
authors.lastname: Fraser-Bell
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Aaron
authors.initials: A
authors.lastname: Yeung
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Anna
authors.initials: A
authors.lastname: Campain
authors.affiliation: Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear 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, University of Sydney, Sydney, Australia.|Ophthalmology Department, Australian School of Advanced Medicine, Macquarie University, Sydney, Australia.
authors.forename: Godfrey J
authors.initials: GJ
authors.lastname: Quin
authors.affiliation: Lions Eye Institute, Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Ian L
authors.initials: IL
authors.lastname: McAllister
authors.affiliation: National Institute for Health Research Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
authors.forename: Pearse A
authors.initials: PA
authors.lastname: Keane
authors.affiliation: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, Australia.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Gillies
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000068258:Bevacizumab / Q000008:administration & dosage*; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D005654:Fundus Oculi; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D005938:Glucocorticoids; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D003907:Dexamethasone
keywords: Clinical Trial; Drugs; Macula; Retina; Treatment other