Table 4.
Adverse events up to one year: ranibizumab vs. control
| Ocular adverse event* | 0.3 mg ranibizumab n = 196 |
0.5 mg ranibizumab n = 201 |
All doses ranibizumab n = 397 |
Control n = 206 |
RR [95% CI] All doses vs. control |
|---|---|---|---|---|---|
| Endophthalmitis | 0 | 2 (< 1%) | 2 (< 1%) | 0 | 2.60 [0.13, 53.92] |
| Retinal detachment | 1 (< 1%) | 0 | 1 (< 1%) | 1 (< 1%) | 0.52 [0.03, 8.25] |
| Traumatic cataract | 18 (9%) | 22 (11%) | 40 (10%) | 14 (7%) | 1.48 [0.83, 2.66] |
| Retinal hemorrhage | 2 (1%) | 0 | 2 (< 1%) | 2 (< 1%) | 0.52 [0.07, 3.66] |
| Vitreous hemorrhage | 1 (< 1%) | 0 | 1 (< 1%) | 0 | 1.56 [0.06, 38.13] |
| Uveitis | 0 | 1 (< 1%) | 1 (< 1%) | 0 | 1.56 [0.06, 38.13] |
| Elevated intraocular pressure (30 mmHg or more increase) | 13 (7%) | 17 (8%) | 30 (8%) | 7 (3%) | 2.22 [0.99, 4.98] |
| Ocular inflammation (trace to 4+) | 21 (11%) | 26 (13%) | 47 (12%) | 9 (4%) | 2.71 [1.36, 5.42] |
| Non-ocular adverse event* | 0.3 mg ranibizumab n = 196 |
0.5 mg ranibizumab n = 201 |
All doses ranibizumab n = 397 |
Control n = 206 |
RR [95% CI] All doses vs. control |
|---|---|---|---|---|---|
| Death | 3 (2%) | 2 (<1%) | 5 (1%) | 2 (< 1%) | 1.30 [0.25, 6.63] |
| Myocardial infarction | 1 (< 1%) | 3 (1%) | 4 (1%) | 1 (< 1%) | 2.08 [0.23, 18.45] |
| Stroke or cerebral infarction | 1 (< 1%) | 1 (< 1%) | 2 (< 1%) | 1 (< 1%) | 1.04 [0.09, 11.38] |
| Ischemic cardiomyopathy | 0 | 0 | 0 | 1 (< 1%) | 0.17 [0.01, 4.24] |
| Treatment-emergent hypertension | 7 (4%) | 15 (7%) | 22 (6%) | 17 (8%) | 0.67 [0.36, 1.24] |
| Non-ocular hemorrhage | 9 (5%) | 13 (6%) | 22 (6%) | 6 (3%) | 1.90 [0.78, 4.62] |
CI: confidence interval
RR: risk ratio
Adverse events experienced by 420 participants in the ANCHOR 2006 study and 183 participants in the PIER 2008 study. Adverse events at one-year follow up not reported in MARINA 2006.