Table 5.

Adverse events up to two years: ranibizumab vs. control

Ocular adverse event*	0.3 mg ranibizumab n = 434	0.5 mg ranibizumab n = 440	All doses ranibizumab n = 874	Control n = 441	RR [95% CI] All doses vs. control
Endophthalmitis	2 (< 1%)	6 (1%)	8 (< 1%)	0	8.59 [0.50, 148.44]
Retinal detachment	2 (< 1%)	0	2 (< 1%)	2 (< 1%)	0.50 [0.07, 3.57]
Traumatic cataract	65 (15%)	76 (17%)	141 (16%)	57 (13%)	1.25 [0.94, 1.66]
Retinal hemorrhage	1 (< 1%)	0	1 (< 1%)	1 (< 1%)	0.50 [0.03, 8.05]
Vitreous hemorrhage	3 (< 1%)	1 (< 1%)	4 (< 1%)	2 (< 1%)	1.01 [0.19, 5.49]
Uveitis	3 (< 1%)	4 (< 1%)	7 (<1%)	0	7.58 [0.43, 132.36]
Elevated intraocular pressure (30 mmHg or more increase)**	45 (15%)	61 (20%)	106 (18%)	11 (4%)	4.81 [2.63, 8.81]
Ocular inflammation (1+ to 4+)	32 (7%)	30 (7%)	62 (7%)	8 (2%)	3.91 [1.89, 8.09]

Non-ocular adverse event*	0.3 mg ranibizumab n = 434	0.5 mg ranibizumab n = 440	All doses ranibizumab n = 874	Control n = 441	RR [95% CI] All doses vs. control
Death	12 (3%)	9 (2%)	21 (2%)	13 (3%)	0.82 [0.41, 1.61]
Myocardial infarction	7 (2%)	8 (2%)	15 (2%)	7 (2%)	1.08 [0.44, 2.63]
Stroke or cerebral infarction	6 (1%)	6 (1%)	12 (1%)	5 (1%)	1.21 [0.43, 3.42]
Ischemic cardiomyopathy	0	0	0	1 (< 1%)	0.17 [0.01, 4.12]
Treatment-emergent hypertension	60 (14%)	69 (16%)	129 (15%)	68 (15%)	0.96 [0.73, 1.25]
Nonocular hemorrhage	38 (9%)	40 (9%)	78 (9%)	24 (5%)	1.64 [1.05, 2.55]

CI: confidence interval

RR: risk ratio

^*Adverse events experienced by 420 participants in the ANCHOR 2006 study; 713 participants in the MARINA 2006 study; and 182 participants in the PIER 2008 study.

^**Adverse events for elevated intraocular pressure not reported in the ANCHOR 2006 study at two-year follow up (n = 297 in 0.3 mg ranibizumab group, n = 300 in 0.5 mg ranibizumab group, and n = 298 in 0.3 mg control group).