title: Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of Ozurdex (dexamethasone intravitreal implant) 0.7 mg in the treatment of diabetic macular edema in vitrectomized eyes.
  
  
  METHODS
  This was a prospective, multicenter, open-label, 26-week study. Fifty-five patients with treatment-resistant diabetic macular edema and a history of previous pars plana vitrectomy in the study eye received a single intravitreal injection of 0.7-mg dexamethasone intravitreal implant. The primary efficacy outcome measure was the change in central retinal thickness from baseline to Week 26 measured by optical coherence tomography.
  
  
  RESULTS
  The mean age of patients was 62 years. The mean duration of diabetic macular edema was 43 months. The mean (95% confidence interval) change from baseline central retinal thickness (403 μm) was -156 μm (-190, -122 μm) at Week 8 (P < 0.001) and -39 μm (-65, -13 μm) at Week 26 (P = 0.004). The mean (95% CI) increase in best-corrected visual acuity from baseline (54.5 letters) was 6.0 letters (3.9, 8.1 letters) at Week 8 (P < 0.001) and 3.0 letters (0.1, 6.0 letters) at Week 26 (P = 0.046). At Week 8, 30.4% of patients had gained ≥10 letters in best-corrected visual acuity. Conjunctival hemorrhage, conjunctival hyperemia, eye pain, and increased intraocular pressure were the most common adverse events.
  
  
  CONCLUSIONS
  Treatment with dexamethasone intravitreal implant led to statistically and clinically significant improvements in both vision and vascular leakage from diabetic macular edema in difficult-to-treat vitrectomized eyes and had an acceptable safety profile.
authors.affiliation: Retina-Vitreous Associates Medical Group, Los Angeles, California, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
authors.forename: David
authors.initials: D
authors.lastname: Faber
authors.forename: Sunil
authors.initials: S
authors.lastname: Gupta
authors.forename: Sunil S
authors.initials: SS
authors.lastname: Patel
authors.forename: Homayoun
authors.initials: H
authors.lastname: Tabandeh
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Li
authors.forename: Charlie C
authors.initials: CC
authors.lastname: Liu
authors.forename: Jean
authors.initials: J
authors.lastname: Lou
authors.forename: Scott M
authors.initials: SM
authors.lastname: Whitcup
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D004343:Drug Implants; D005260:Female; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012160:Retina / Q000473:pathology; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014821:Vitrectomy; D014822:Vitreous Body
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone