The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema

Ophthalmology. 2011 Sep;118(9):1819-26. doi: 10.1016/j.ophtha.2011.02.018. Epub 2011 May 5.


Purpose: 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).

Design: Multicenter, randomized, double-masked, phase 2 clinical trial.

Participants: 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.

Main outcome measures: 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.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Diabetes Mellitus, Type 1 / complications
  • Diabetes Mellitus, Type 2 / complications
  • Diabetic Retinopathy / drug therapy
  • Diabetic Retinopathy / physiopathology
  • Diabetic Retinopathy / surgery
  • Diabetic Retinopathy / therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Intravitreal Injections
  • Laser Coagulation*
  • Macular Edema / drug therapy
  • Macular Edema / physiopathology
  • Macular Edema / surgery
  • Macular Edema / therapy*
  • Male
  • Middle Aged
  • Receptors, Vascular Endothelial Growth Factor
  • Recombinant Fusion Proteins / administration & dosage*
  • Recombinant Fusion Proteins / adverse effects
  • Retina / pathology
  • Retreatment
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Visual Acuity / physiology


  • Recombinant Fusion Proteins
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor