title: The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema.
abstract: OBJECTIVE
  To determine whether different doses and dosing regimens of intravitreal vascular endothelial growth factor (VEGF) Trap-Eye are superior to focal/grid photocoagulation in eyes with diabetic macular edema (DME).
  
  
  METHODS
  Multicenter, randomized, double-masked, phase 2 clinical trial.
  
  
  METHODS
  A total of 221 diabetic patients with clinically significant macular edema involving the central macula.
  
  
  METHODS
  Patients were assigned to 1 of 5 treatment regimens: 0.5 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye every 4 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then every 8 weeks; 2 mg VEGF Trap-Eye for 3 initial monthly doses and then on an as-needed (PRN) basis; or macular laser photocoagulation. Assessments were completed at baseline and every 4 weeks thereafter.
  
  
  METHODS
  Mean change in visual acuity and central retinal thickness (CRT) at 24 weeks.
  
  
  RESULTS
  Patients in the 4 VEGF Trap-Eye groups experienced mean visual acuity benefits ranging from +8.5 to +11.4 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters versus only +2.5 letters in the laser group (P ≤ 0.0085 for each VEGF Trap-Eye group vs. laser). Gains from baseline of 0+, 10+, and 15+ letters were seen in up to 93%, 64%, and 34% of VEGF Trap-Eye groups versus up to 68%, 32%, and 21% in the laser group, respectively. Mean reductions in CRT in the 4 VEGF Trap-Eye groups ranged from -127.3 to -194.5 μm compared with only -67.9 μm in the laser group (P = 0.0066 for each VEGF Trap-Eye group vs. laser). VEGF Trap-Eye was generally well tolerated. Ocular adverse events in patients treated with VEGF Trap-Eye were generally consistent with those seen with other intravitreal anti-VEGF agents.
  
  
  CONCLUSIONS
  Intravitreal VEGF Trap-Eye produced a statistically significant and clinically relevant improvement in visual acuity when compared with macular laser photocoagulation in patients with DME.
authors.affiliation: Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University, Baltimore, Maryland, USA. ddo@jhmi.edu
authors.forename: Diana V
authors.initials: DV
authors.lastname: Do
authors.forename: Ursula
authors.initials: U
authors.lastname: Schmidt-Erfurth
authors.forename: Victor H
authors.initials: VH
authors.lastname: Gonzalez
authors.forename: Carmelina M
authors.initials: CM
authors.lastname: Gordon
authors.forename: Michael
authors.initials: M
authors.lastname: Tolentino
authors.forename: Alyson J
authors.initials: AJ
authors.lastname: Berliner
authors.forename: Robert
authors.initials: R
authors.lastname: Vitti
authors.forename: Rene
authors.initials: R
authors.lastname: Rückert
authors.forename: Rupert
authors.initials: R
authors.lastname: Sandbrink
authors.forename: David
authors.initials: D
authors.lastname: Stein
authors.forename: Ke
authors.initials: K
authors.lastname: Yang
authors.forename: Karola
authors.initials: K
authors.lastname: Beckmann
authors.forename: Jeff S
authors.initials: JS
authors.lastname: Heier
mesh_terms: D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D058449:Intravitreal Injections; D017075:Laser Coagulation; D008269:Macular Edema / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D040262:Receptors, Vascular Endothelial Growth Factor; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D012160:Retina / Q000473:pathology; D019233:Retreatment; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D011993:Recombinant Fusion Proteins; C533178:aflibercept; D040262:Receptors, Vascular Endothelial Growth Factor