Table 5. Systemic safety.
| Study | Investigational product |
Death (any cause) [%], (number)
|
Myocardial infarction [%], (number)
|
Cerebrovascular accident [%], (number)
|
Nonocular hemorrhage [%], (number)
|
Infections [%], (number)
|
||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 mg | 4 mg | Obs. | 1 mg | 4 mg | Obs. | 1 mg | 4 mg | Obs. | 1 mg | 4 mg | Obs. | 1 mg | 4 mg | Obs. | ||||||||||||
| CRVO | SCORE 2009, 2011 [5,32] | Triamcinolone | 1.1% (1) | 2.2% (2) | 0 | Nr | Nr | Nr | 15% | 19% | 10% | |||||||||||||||
| 12-24 months | 1% (1) | 3.4% (3) | 1.1% (1) | |||||||||||||||||||||||
| CRVO/ BRVO | GENEVA 2011 [8] | Dexamethasone implant | Nr | Nr | Nr | Nr | Nr | |||||||||||||||||||
| 1.25 mg | Sham/ 1.25 mg | |||||||||||||||||||||||||
| CRVO | Epstein 2012 [26] | Bevacizumab | Nr | Nr | 0 | 3.3% (1) | Nr | Nr | ||||||||||||||||||
| 2 mg | Sham/ 2 mg | 2 mg | Sham/ 2 mg | 2 mg | Sham/ 2 mg | 2 mg | Sham/ 2 mg | 2 mg | Sham/ 2 mg | |||||||||||||||||
| CRVO | COPERNICUS 2013 [20] | Aflibercept | 0 | 2.7% (2) | 0.9% (1) | 1.7% (1) | 0 | 1.7% (1) | Nr | 7.9% NPG, 7.9% URI | 6.8% NPG, 5.4% URI | |||||||||||||||
| 0.3/ 0.5 mg | 0.5/ 0.5 mg | Sham/ 0.5 mg | 0.3/ 0.5 mg | 0.5/ 0.5 mg | Sham/ 0.5 mg | 0.3/ 0.5 mg | 0.5/ 0.5 mg | Sham/ 0.5 mg | 0.3/ 0.5 mg | 0.5/ 0.5 mg | Sham/ 0.5 mg | 0.3/ 0.5 mg | 0.5/ 0.5 mg | Sham/ 0.5 mg | ||||||||||||
| CRVO | CRUISE 2011 [22] | Ranibizumab | 0 | 0.8% (1) | 0 | 0.8% (1) | 0.8% (1) | 0.8% (1) | 0.8% | 1.6% # | 0 | 0 | Nr | |||||||||||||
| CRVO/ BRVO | HORIZON 2012 [30] | Ranibizumab | 1% (1) | 3% (3) | 3.1% (3) | 0.9% (1) | 0 | 0 | 0.9% (1) | 2.1% (2) | 1% (1) | 0 | 2% (2) | 2.1% (2) | 7.3% (7) NPG | 7.1% (7) NPG | 7.3% (7) NPG | |||||||||
| BRVO | BRAVO 2011 [23] | Ranibizumab | 0 | 0 | 0 | 0 | 0.8% (1) | 0.9% (1) | 0.7% (1) | 0.8% (1) | 0.8% (1) | 1.5% (2) | 0.8% (1) | 0 | Nr | |||||||||||
| BRVO/ CRVO | HORIZON 2012 [30] | Ranibizumab | 1% (1) | 2.9% (3) | 0 | 1% (1) | 1% (1) | 0 | 2.9% | 0 | 1% (1) | 0 | 2.9% (3) | 0 | 5.3% NPG | 1% (1) NPG | 7.5% (7) NPG | |||||||||
| 1 mg | 4 mg | Grid | 1 mg | 4 mg | Grid | 1 mg | 4 mg | Grid | 1 mg | 4 mg | Grid | 1 mg | 4 mg | Grid | ||||||||||||
| BRVO | SCORE 2009, 2011 [4,32] | Triamcinolone | 2.2% (3) | 1.4% (2) | 2.1 % (3) | Nr | Nr | Nr | 16% | 15% | 10% | |||||||||||||||
| 12-24 months | (2) | (7) | (2) | |||||||||||||||||||||||
| BRVO | Parodi 2008 [27] | Triamcinolone | Nr | Nr | Nr | Nr | Nr | |||||||||||||||||||
| BRVO | Russo 2009 [28] | Bevacizumab | Nr | Nr | Nr | Nr | Nr | |||||||||||||||||||
| BRVO | Donati 2012 [29] | Bevacizumab | Nr | Nr | Nr | Nr | Nr | |||||||||||||||||||
Obs.: Observation, Nr: not reported, NPG: Nasopharyngitis, URI: upper respiratory infection
# sum of one TIA (0.8%) and one ischemic stroke (0.8%)