Table 9

Ranibizumab safety data

READ-2 study2847RESOLVE study36RESTORE study24RISE study38RIDE study38
Number of patientsIVR: n=42; L: n=42; IVRL: n=42IVR0.3: n=51; IVR0.5: n=51; C: n=49IVR: n=116; IVRL: n=118; L: n=111IVR0.3: 125; IVR0.5: 126; C: 123IVR0.3: 125; IVR0.5: 124; C: 127
Ocular adverse events
 Eye painNRIVR0.3: n=9 (18%); IVR0.5: n=9 (18%); C: n=10 (20%)IVR: n=13 (11%); IVRL: n=10 (8%); L: n=12 (11%)IVR0.3: 26%; IVR0.5: 21%; C: 19%IVR0.3: 8%; IVR0.5: 12.9%; C: 7.1%
 Conjunctival hyperaemiaNRNRIVR: n=9 (8%); IVRL: n=6 (5%); L: n=6 (5%)NRNR
 Conjunctival haemorrhageNRIVR0.3: n=10 (20%); IVR0.5: n=13 (25%); C: n=7 (14%)IVR: n=8 (7%); IVRL: n=10 (8%); L: n=0IVR0.3: 54%; IVR0.5: 52%; C: 32%IVR0.3: 40.8%; IVR0.5: 50%; C: 31.5%
 IOP increaseNRIVR0.3: n=6 (12%); IVR0.5: n=15 (29%); C: n=1 (2%)IVR: n=1 (<1%); IVRL: n=1 (<1%);IVR0.3: 20%; IVR0.5: 14%; C: 2%IVR0.3 : 15.2%;IVR0.5: 18.5%; C: 11%
 Vitreous haemorrhageIVR: n=1 (2%); L: n=4 (10%); IVRL: n=3 (7%)IVR0.3: n=1 (2%); IVR0.5: n=0; C: n=0NRIVR0.3: 3.2%; IVR0.5: 3.2%; C: 13%IVR0.3: 0.8%; IVR0.5: 2.4%; C: 15%
 Substantial worsening of DMOL: n=1 (2%)NRNRNR
 Retinal ischaemiaNRIVR0.3: n=0; IVR0.5: n=1 (2%); C: n=0NRNRNR
 Retinal artery occlusionNRIVR0.3: n=0; IVR0.5: n=1 (2%); C: n=0NRNRNR
 EndophthalmitisNRIVR0.3: n=1 (2%); IVR0.5: n=1 (2%); C: n=0NRIVR0.3: 0.8%; IVR0.5: 0; C: 0IVR0.3+IVR0.5: 1.2%; C: 0%
 Retinal detachmentNRIVR0.3: n=0; IVR0.5: n=0; C: n=1 (2%)NRIVR0.3: 0.8%; IVR0.5: 0; C: 0.8%IVR0.3+IVR0.5: 0.4%; C: 0%
 NeovascularisationNRNRNRIVR0.3: 0; IVR0.5: 0; C: 0.8%IVR0.3: 0.8%; IVR0.5: 0.8%; C: 5.5%
 Traumatic cataractNRNRNRIVR0.3: 0.8%; IVR0.5: 0.8%; C: 0IVR0.3+IVR0.5: 0.4%; C: 0%
 UveitisNRNRNRNRIVR0.3+IVR0.5: 0.4%; C: 0%
 Macular oedemaNRNRNRIVR0.3: 16.8%; IVR0.5: 20.6%; C: 21.1%IVR0.3: 19.2%; IVR0.5: 13.7%; C: 20.5%
 Retinal exudatesNRNRNRIVR0.3: 19.2%; IVR0.5: 17.5%; C: 20.3%IVR0.3: 16%; IVR0.5: 15.3%; C: 11%
 Retinal haemorrhageNRNRNRIVR0.3: 12.8%; IVR0.5: 12.7%; C: 20.3%IVR0.3: 15.2%; IVR0.5: 22.6%; C: 18.9%
 CataractNRNRNRIVR0.3: 16.8%; IVR0.5: 11.9%; C: 14.6%IVR0.3: 20%; IVR0.5: 23.4%; C: 23.6%
 Vitreous detachmentNRNRNRIVR0.3: 13.6%; IVR0.5: 11.1%; C: 15.4%IVR0.3: 8.8%; IVR0.5: 12.9%; C: 15%
 Ocular hyperemiaNRNRNRIVR0.3: 15.2%; IVR0.5: 11.1%; C: 10.6%IVR0.3: 3.2%; IVR0.5: 3.2%; C: 7.9%
 Vitreous floatersNRNRNRIVR0.3: 12.8%; IVR0.5: 14.3%; C: 5.7%IVR0.3: 7.2%; IVR0.5: 8.1%; C: 3.1%
 Eye irritationNRNRNRIVR0.3: 10.4%; IVR0.5: 9.5%; C: 6.5%IVR0.3: 5.6%; IVR0.5: 5.6%; C: 3.1%
 Foreign body sensation in eyesNRNRNRIVR0.3: 12.8%; IVR0.5: 7.1%; C: 4.1%IVR0.3: 8%; IVR0.5: 2.4%; C: 5.5%
Systematic adverse events
 Arterial thromboembolic eventsStroke in 1 pt (2%) in IVRL group- not related to study drugIVR0.3: n=0; IVR0.5: n=3 (6%); C: n=2 (4%)IVR: n=6 (5%); IVRL: n=1 (<1%); L: n=1 (<1%)IVR0.3: 3.2% (n=1 stroke); IVR0.5: 7.9% (n=5 strokes); C: 7.3% (n=2 strokes)IVR0.3: 1.6% (stroke), 5.6% (heart attack); IVR0.5: 2.4% (stroke), 2.4% (heart attack); C: 1.6% (stroke), 5.6% (heart attack)
 HypertensionNRIVR0.3: n=4 (8%); IVR0.5: n=5 ((10%); C: n=5 (10%)IVR: n=9 (8%); IVRL: n=6 (5%); L: n=9 (8%)Serious
IVR0.3: 0.8%; IVR0.5: 3.2%; C: 0.8%
Serious
IVR0.3: 1.6%; IVR0.5: 1.6%; C: 0%
 Non-ocular haemorrhageNRIVR0.3: n=1 (2%); IVR0.5: n=1 (2%); C: n=0IVR: n=1 (<1%); IVRL: n=0; L: n=1 (<1%)NRNR
 ProteinuriaNRNRIVR: n=1 (<1%); IVRL: n=1 (<1%); L: n=0NRNR
 Deaths1 (2%) due to CVA in IVRL groupNRIVR: n=2 (2%); IVRL: n=2 (2%); L: n=2 (2%)IVR0.3: 2.4%; IVR0.5: 4%; C: 0.8%IVR0.3: 3.2%; IVR0.5: 4.8%; C: 1.6%
  • C, control; DMO, diabetic macular oedema; IOP, intraocular pressure; IVR, intravitreal ranibizumab; IVRL, intravitreal ranibizumab plus laser; L, laser; NR, not reported.