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VEGF Trap-Eye in Patients with Diabetic Macular Edema (DA VINCI)

August 1, 2012

Clinical trial

One-year outcomes of the da Vinci Study of VEGF Trap-Eye in eyes with diabetic macular edema.

Do DV, Nguyen QD, Boyer D, Schmidt-Erfurth U, Brown DM, Vitti R, Berliner AJ, Gao B, Zeitz O, Ruckert R, Schmelter T, Sandbrink R, Heier JS.

Ophthalmology. 2012 Aug;119(8):1658-65.
Full text | Metrics.

Main finding: VEGF Trap-Eye resulted in significant visual gain at 1 year.

 

  • Purpose: To compare different doses and dosing regimens of Vascular Endothelial Growth Factor Trap-Eye with laser photocoagulation in eyes with diabetic macular edema
  • Study type: Randomized controlled trial
  • Condition: Diabetic Macular Edema

Participants: Type 1 or 2 DM, Ci-DME , VA 20/40-20/320 (6/12-6/96) and central subfield thickness ≥250 μm

 

  • n=221

 

Intervention:

 

  • Group 1: Aflibercept (AFLI) 0.5mg every 4 weeks (0.5q4)
  • Group 2: Aflibercept 2mg every 4 weeks (2q4)
  • Group 3: Aflibercept 2mg every 8 weeks after 3 initial monthly doses (2q8)
  • Group 4: Aflibercept 2mg PRN after 3 initial monthly doses (2PRN)
  • Group 5: Laser (macular)
Outcomes AFLI 0.5q4 AFLI 2q4 AFLI 2q8 AFLI 2PRN Laser
Mean BCVA change (letters) at 1 year +11.0 +13.1 +9.7 +12.0 -1.3
BCVA gain ≥ 15 letters (Proportion of patients) 40.9% 45.5% 23.8% 42.2% 11.4%

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