title: Vascular endothelial growth factor Trap-Eye for macular edema secondary to central retinal vein occlusion: six-month results of the phase 3 COPERNICUS study.
abstract: OBJECTIVE
  To assess the efficacy and safety of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye in eyes with macular edema secondary to central retinal vein occlusion (CRVO).
  
  
  METHODS
  Multicenter, randomized, prospective, controlled trial.
  
  
  METHODS
  One hundred eighty-nine eyes with macular edema secondary to CRVO.
  
  
  METHODS
  Eyes were randomized 3:2 to receive VEGF Trap-Eye 2 mg or sham injection monthly for 6 months.
  
  
  METHODS
  The proportion of eyes with a ≥15-letter gain or more in best-corrected visual acuity (BCVA) at week 24 (primary efficacy end point), mean changes in BCVA and central retinal thickness (CRT), and proportion of eyes progressing to neovascularization of the anterior segment, optic disc, or elsewhere in the retina.
  
  
  RESULTS
  At week 24, 56.1% of VEGF Trap-Eye treated eyes gained 15 letters or more from baseline versus 12.3% of sham-treated eyes (P<0.001). The VEGF Trap-Eye treated eyes gained a mean of 17.3 letters versus sham-treated eyes, which lost 4.0 letters (P<0.001). Central retinal thickness decreased by 457.2 μm in eyes treated with VEGF Trap-Eye versus 144.8 μm in sham-treated eyes (P<0.001), and progression to any neovascularization occurred in 0 and 5 (6.8%) of eyes treated with VEGF Trap-Eye and sham-treated eyes, respectively (P = 0.006). Conjunctival hemorrhage, reduced visual acuity, and eye pain were the most common adverse events (AEs). Serious ocular AEs were reported by 3.5% of VEGF Trap-Eye patients and 13.5% of sham patients. Incidences of nonocular serious AEs generally were well balanced between both groups.
  
  
  CONCLUSIONS
  At 24 weeks, monthly intravitreal injection of VEGF Trap-Eye 2 mg in eyes with macular edema resulting from CRVO improved visual acuity and CRT, eliminated progression resulting from neovascularization, and was associated with a low rate of ocular AEs related to treatment.
authors.affiliation: Retina Vitreous Associates Medical Group, Los Angeles, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Boyer
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Heier
authors.forename: David M
authors.initials: DM
authors.lastname: Brown
authors.forename: W Lloyd
authors.initials: WL
authors.lastname: Clark
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.forename: Georg
authors.initials: G
authors.lastname: Groetzbach
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.forename: Xiaoping
authors.initials: X
authors.lastname: Zhu
authors.forename: Karola
authors.initials: K
authors.lastname: Beckmann
authors.forename: Julia A
authors.initials: JA
authors.lastname: Haller
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D058447:Eye Pain / Q000209:etiology; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D008297:Male; D011446:Prospective Studies; D040262:Receptors, Vascular Endothelial Growth Factor; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D020533:Angiogenesis Inhibitors; D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor