title: Vision-Related Quality of Life Outcomes in the BEVORDEX Study: A Clinical Trial Comparing Ozurdex Sustained Release Dexamethasone Intravitreal Implant and Bevacizumab Treatment for Diabetic Macular Edema.
abstract: OBJECTIVE
  To determine the patient-centered effectiveness of treatment with the slow-release dexamethasone intravitreal implant (DEX implant) and intravitreal bevacizumab using the Impact of Vision Impairment Questionnaire (IVI), a vision-related quality of life (VRQoL) measure, in patients with visual impairment secondary to center-involving diabetic macular edema (DME).
  
  
  METHODS
  Patients with DME were enrolled in a phase 2, prospective, multicenter, randomized, single-masked clinical trial and received either DEX implant 4 monthly or bevacizumab monthly, both pro re nata. Vision-related quality of life was measured at baseline and 24 months, using the IVI's three component scales, namely reading, mobility, and emotional well-being. Rasch analysis was used to generate interval-level estimates of VRQoL, which were then analyzed using t-tests to assess changes over time.
  
  
  RESULTS
  Forty-eight patients completed the main study; 43 (90%) answered the IVI at the baseline and 24-month (final efficacy) visits. Vision-related quality of life improved significantly, with average increases of 1.44, 0.99, and 1.49 logits, for the reading, mobility, and emotional well-being scales respectively, from baseline to 24 months, (P < 0.001). There was no significant between-group difference in improvement in VRQoL in the DEX implant only compared with the bevacizumab-only group, in any of the three scales listed above (with 1.41, 1.08, and 2.11 logits improvement, in reading, mobility, and emotional well-being, respectively, for DEX implant group, compared with 1.48, 1.06, and 2.11 for bevacizumab; P values > 0.1.).
  
  
  CONCLUSIONS
  We found that both DEX implant and bevacizumab treatment result in significant and similar improvements in VRQoL in patients with DME over a 24-month period. (Clinicaltrials.gov identifier NCT01298076).
authors: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors: Christine
authors: C
authors: Aroney
authors: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors: Samantha
authors: S
authors: Fraser-Bell
authors: The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia 3Singapore Eye Research Institute, National University of Singapore, Singapore 4Duke-NUS Medical School, Singapore.
authors: Ecosse L
authors: EL
authors: Lamoureux
authors: The Save Sight and Eye Health Institute, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
authors: Mark C
authors: MC
authors: Gillies
authors: The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia.
authors: Lyndell L
authors: LL
authors: Lim
authors: The Centre for Eye Research, University of Melbourne, Royal Victoria Eye and Ear Hospital, Melbourne, Australia 3Singapore Eye Research Institute, National University of Singapore, Singapore.
authors: Eva K
authors: EK
authors: Fenwick
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000068258:Bevacizumab / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004343:Drug Implants; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; 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; D011788:Quality of Life; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity
chemical_list: D020533:Angiogenesis Inhibitors; D003692:Delayed-Action Preparations; D004343:Drug Implants; D005938:Glucocorticoids; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D003907:Dexamethasone