title: PROSPECTIVE RANDOMIZED SUBJECT-MASKED STUDY OF INTRAVITREAL BEVACIZUMAB MONOTHERAPY VERSUS DEXAMETHASONE IMPLANT MONOTHERAPY IN THE TREATMENT OF PERSISTENT DIABETIC MACULAR EDEMA.
abstract: OBJECTIVE
  To compare intravitreal bevacizumab monotherapy with intravitreal dexamethasone delayed delivery system monotherapy for persistent diabetic macular edema.
  
  
  METHODS
  Single-center, randomized, subject-masked study of eyes with persistent diabetic macular edema, defined as central subfield thickness (CST) >340 μm despite ≥3 anti-vascular endothelial growth factors injections within 5 months. The intravitreal bevacizumab monotherapy (n = 23 eyes) and delayed delivery system monotherapy (n = 27 eyes) groups received treatments q1month and q3months, respectively.
  
  
  RESULTS
  Baseline best-corrected visual acuity and CST were similar in the two groups. At Month 7, the mean final best-corrected visual acuity (mean ± SD) was 65 ± 16 letters (mean Snellen visual acuity 20/50) and 64 ± 11 letters (20/50) (P = 0.619), the mean change in best-corrected visual acuity was +5.6 ± 6.1 and +5.8 ± 7.6 letters (P = 0.785), the mean final CST was 471 ± 157 and 336 ± 89 μm (P = 0.001), and the mean change in CST was -13 ± 105 and -122 ± 120 μm (P = 0.005) in the intravitreal bevacizumab monotherapy and delayed delivery system monotherapy groups, respectively. The number of injections was 7.0 ± 0.2 and 2.7 ± 0.5 (P < 0.001) in the 2 groups.
  
  
  CONCLUSIONS
  The two groups had similar best-corrected visual acuity gains. The delayed delivery system monotherapy group achieved a significantly greater reduction of CST compared with the intravitreal bevacizumab monotherapy group, with a q3month interval of treatment, and had no recurrent edema at any visit.
authors.affiliation: *Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana; and †Midwest Eye Institute, Indianapolis, Indiana.
authors.forename: Sanket U
authors.initials: SU
authors.lastname: Shah
authors.forename: Ashley
authors.initials: A
authors.lastname: Harless
authors.forename: Laura
authors.initials: L
authors.lastname: Bleau
authors.forename: Raj K
authors.initials: RK
authors.lastname: Maturi
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019591:Pseudophakia / Q000209:etiology / Q000503:physiopathology; D041623:Tomography, Optical Coherence; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D004343:Drug Implants; D005938:Glucocorticoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D003907:Dexamethasone