title: Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema.
abstract: OBJECTIVE
  To evaluate Ozurdex (dexamethasone intravitreal implant [DEX implant]; Allergan, Inc, Irvine, CA) 0.7 mg combined with laser photocoagulation compared with laser alone for treatment of diffuse diabetic macular edema (DME).
  
  
  METHODS
  Randomized, controlled, multicenter, double-masked, parallel-group, 12-month trial.
  
  
  METHODS
  Two hundred fifty-three patients with retinal thickening and impaired vision resulting from diffuse DME in at least 1 eye (the study eye) were enrolled.
  
  
  METHODS
  Patients were randomized to treatment in the study eye with DEX implant at baseline plus laser at month 1 (combination treatment; n = 126) or sham implant at baseline and laser at month 1 (laser alone; n = 127) and could receive up to 3 additional laser treatments and 1 additional DEX implant or sham treatment as needed.
  
  
  METHODS
  The primary efficacy variable was the percentage of patients who had a 10-letter or more improvement in best-corrected visual acuity (BCVA) from baseline at month 12. Other key efficacy variables included the change in BCVA from baseline and the area of vessel leakage evaluated with fluorescein angiography. Safety variables included adverse events and intraocular pressure (IOP).
  
  
  RESULTS
  The percentage of patients who gained 10 letters or more in BCVA at month 12 did not differ between treatment groups, but the percentage of patients was significantly greater in the combination group at month 1 (P<0.001) and month 9 (P = 0.007). In patients with angiographically verified diffuse DME, the mean improvement in BCVA was significantly greater with DEX implant plus laser treatment than with laser treatment alone (up to 7.9 vs. 2.3 letters) at all time points through month 9 (P ≤ 0.013). Decreases in the area of diffuse vascular leakage measured angiographically were significantly larger with DEX implant plus laser treatment through month 12 (P ≤ 0.041). Increased IOP was more common with combination treatment. No surgeries for elevated IOP were required.
  
  
  CONCLUSIONS
  There was no significant between-group difference at month 12. However, significantly greater improvement in BCVA, as demonstrated by changes from baseline at various time points up to 9 months and across time based on the area under the curve analysis, occurred in patients with diffuse DME treated with DEX implant plus laser than in patients treated with laser alone.
  
  
  BACKGROUND
  Proprietary or commercial disclosure may be found after the references.
authors.affiliation: Texas Retina Associates, Arlington, Texas 76012, USA. dcallanan@texasretina.com
authors.forename: David G
authors.initials: DG
authors.lastname: Callanan
authors.forename: Sunil
authors.initials: S
authors.lastname: Gupta
authors.forename: David S
authors.initials: DS
authors.lastname: Boyer
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Ciulla
authors.forename: Michael A
authors.initials: MA
authors.lastname: Singer
authors.forename: Baruch D
authors.initials: BD
authors.lastname: Kuppermann
authors.forename: Ching-Chi
authors.initials: CC
authors.lastname: Liu
authors.forename: Xiao-Yan
authors.initials: XY
authors.lastname: Li
authors.forename: David A
authors.initials: DA
authors.lastname: Hollander
authors.forename: Rhett M
authors.initials: RM
authors.lastname: Schiffman
authors.forename: Scott M
authors.initials: SM
authors.lastname: Whitcup
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002199:Capillary Permeability; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage*; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012171:Retinal Vessels / Q000378:metabolism; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body / Q000187:drug effects
chemical_list: D004343:Drug Implants; D005938:Glucocorticoids; D003907:Dexamethasone