title: VEGF Trap-Eye for macular oedema secondary to central retinal vein occlusion: 6-month results of the phase III GALILEO study.
abstract: OBJECTIVE
  To evaluate intravitreal VEGF Trap-Eye (VTE) in patients with macular oedema secondary to central retinal vein occlusion (CRVO).
  
  
  METHODS
  In this double-masked study, 177 patients were randomised (3:2 ratio) to intravitreal injections of VTE 2 mg or sham procedure every 4 weeks for 24 weeks. Best-corrected visual acuity was evaluated using the Early Treatment Diabetic Retinopathy Study chart. Central retinal thickness (CRT) was measured with optical coherence tomography.
  
  
  RESULTS
  From baseline until week 24, more patients receiving VTE (60.2%) gained ≥ 15 letters compared with those receiving sham injections (22.1%) (p<0.0001). VTE patients gained a mean of 18.0 letters compared with 3.3 letters with sham injections (p<0.0001). Mean CRT decreased by 448.6 and 169.3 µm in the VTE and sham groups (p<0.0001). The most frequent ocular adverse events in the VTE arm were typically associated with the injection procedure or the underlying disease, and included eye pain (11.5%), increased intraocular pressure (9.6%) and conjunctival haemorrhage (8.7%).
  
  
  CONCLUSIONS
  VTE 2 mg every 4 weeks was efficacious in CRVO with an acceptable safety profile. Vision gains with VTE were significantly higher than with observation/panretinal photocoagulation if needed. Based on these data, VTE may provide a new treatment option for CRVO.
authors.affiliation: Department of Ophthalmology, University of Bonn, Ernst-Abbe-Street 2, Bonn 53127, Germany. frank.holz@ukb.uni-bonn.de
authors.forename: Frank G
authors.initials: FG
authors.lastname: Holz
authors.forename: Johann
authors.initials: J
authors.lastname: Roider
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Ogura
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Korobelnik
authors.forename: Christian
authors.initials: C
authors.lastname: Simader
authors.forename: Georg
authors.initials: G
authors.lastname: Groetzbach
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.forename: Florian
authors.initials: F
authors.lastname: Hiemeyer
authors.forename: Karola
authors.initials: K
authors.lastname: Beckmann
authors.forename: Oliver
authors.initials: O
authors.lastname: Zeitz
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage*; D012160:Retina / Q000473:pathology; D012170:Retinal Vein Occlusion / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor