Table 12

Aflibercept safety

DA VINCI 20103058
Number of patientsIVVTE (all doses) n=175, laser n=44
Ocular adverse events
 Conjunctival hemorrhageAt 6 months: Laser 18.2%, IVVTE 18.9%
At 12 months: Laser 18.2%, IVVTE 26.9%
 IOP increaseAt 6 months: Laser 2.3%, IVVTE 9.7%
At 12 months: Laser 2.3%, IVVTE 9.7%
 Eye painAt 6 months: Laser 4.5%, IVVTE 8.6%
At 12 months: Laser 4.5%, IVVTE 13.7%
 Ocular hyperaemiaAt 6 months: Laser 4.5%, IVVTE 6.3%
At 12 months: Laser 4.5%, IVVTE 7.4%
 Vitreous floatersAt 6 months: Laser 4.5%, IVVTE 5.1%
At 12 months: Laser 4.5%, IVVTE 6.9%
 EndophthalmitisAt 6 months: Laser 0%, IVVTE 1.1%
At 12 months: Laser 0%, IVVTE 1.1%
 UveitisAt 6 months: Laser 0%, IVVTE 0.6%
At 12 months: Laser 0%, IVVTE 0.6%
 Diabetic retinal oedemaAt 6 months: Laser 2.3%, IVVTE 0%
At 12 months: Laser 2.3%, IVVTE 4.6%
 Visual acuity reducedAt 6 months: Laser 2.3%, IVVTE 0%
At 12 months: Laser 2.3%, IVVTE 0%
 Vitreous hemorrhageAt 6 months: Laser 2.3%, IVVTE 0%
At 12 months: Laser 6.8%, IVVTE 0%
 Corneal abrasionAt 6 months: Laser 0%, IVVTE 0.6%
At 12 months: Laser 0%, IVVTE 4.6%
 Retinal tearAt 6 months: Laser 0%, IVVTE 0.6%
At 12 months: NR
Systematic events
 HypertensionAt 6 months: Laser 6.8%, IVVTE 9.7%
At 12 months: Laser 0%, IVVTE 1.7%
 Myocardial infarctionAt 6 months: Laser 0%, IVVTE 1.1%
At 12 months: Laser 0%, IVVTE 1.7%
 Cerebrovascular eventAt 6 months: Laser 0%, IVVTE1.1%
At 12 months: Laser 2.3%, IVVTE 1.7%
 DeathAt 6 months: Laser 0%, IVVTE 1.7%
At 12 months: Laser 2.3%, IVVTE 4%
  • IOP, intraocular pressure; IVVTE, intravitreal vascular endothelial growth factor Trap Eye.