Serious systemic and ocular adverse events reported in included observational studies
| Systemic adverse events | |||
|---|---|---|---|
| Adverse event | Rates (%) | Number of eligible studies contributing data | Percentage of eligible studies reporting zero events |
| Death | 0.4 to 3.8 | 6* | Not applicable |
| Hospitalisation | 32† | 1 | Not applicable |
| Non-ocular haemorrhage | 0.0 | 1 | 100%(n=1)82 |
| Arterial thromboembolism | 0.0 to 1.35‡ | 9 | 78% (n=7)34 38 44 82 85 88 96 |
| Hypertension | 0.0 to 15.6 | 9 | 44% (n=4)42 43 82 96 |
| Myocardial infarction | 0.0 to 8.2 | 10 | 50% (n=5)34 38 56 67 82 |
| Cerebrovascular accident | 0.0 to 8.7 | 11§ | 45% (n=5)34 38 56 67 82 |
| Transient ischaemic attack | 0.4 to 1.0 | 534 | 60% (n=3)34 67 82 |
| Ocular adverse events | |||
| Infectious endophthalmitis | 0.0 to 1.0 | 31¶ | 62% (n=19)29 32 41 43 44 51 56 59 60 65 67 73 76 81 85 86 88 91 96 |
| Retinal detachment | 0.0 to 29.0 | 20 | 75% (n=15)29 32 35 56 65 67 68 76 79 81 85 86 91 95 96 |
| Retinal tear | 0.0 to 15.0 | 14 | 42% (n=6)29 44 52 60 65 85 |
| Anterior chamber reaction | 0.0 to 50.0 | 21** | 57% (n=12)29 41 43 44 51 56 67 68 85 88 91 96 |
| Ocular haemorrhage | 0.0 to 72.0 | 14 | 43% (n=6)32 41 52 56 85 91 |
| Lens damage | 0.0 to 0.5 | 9 | 67% (n=6)41 56 65 67 85 91 |
| Ocular hypertension | 0.0 to 20.0 | 16†† | 50% (n=8)29 32 36 41 65 70 87 91 |
| Visual loss | 0.0 to 50.0 | 9 | 11% (n=1)85 |
Estimates of adverse event incidence were calculated by dividing the number of reported events by the number of patients that received IVB (event rate per patient) or the number of eyes treated (event rate per treated eye).
*One study presented an HR of 1.11 (99% CI 1.01 to 1.23, IVB vs IVR).
†Incidence of systemic adverse events was reported based on number of injections and not patients, 32% (n=222/693 injections).
‡Event rate was presented for a sub-group to the study population living in a specified geographical area.
§ One study reported an HR of 1.57 (99% CI 1.04 to 2.37, IVB vs IVR).
¶Authors of one study stated that the rate of infectious endophthalmitis after an IVB injection of 1.5 mg may be approximately 1:1000.
**One study reported an HR of 1.8 (99% CI 1.2 to 2.8, IVB vs IVR).
††One study reported an HR of 0.81 (99% CI 0.71 to 0.93, IVB vs IVR).