Table 3. Ocular safety – Endophthalmitis, uveitis, retinal detachment, retinal tear, traumatic lens damage.
Study | Investigational product | Total number of injections |
Endophthalmitis [%], (number of eyes)
|
Uveitis [%], (number of eyes)
|
Retinal detachment [%], (number of eyes)
|
Retinal tear [%], (number of eyes) |
Traumatic lens damage [%], (number of eyes) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
CRVO | SCORE 2009, 2011 [5,32] | Triamcinolone | 586 | 0 | 0 | 0 | Nr | Nr | ||||||||||
CRVO/ BRVO | GENEVA 2011 [8,9] | Dexamethasone implant | 1715 implants# | 0 | Nr | Rare | Rare | Nr | ||||||||||
CRVO | Epstein 2012 [26,31] | Bevacizumab | 720 | 0 | Nr | 0 | 0 | Nr | ||||||||||
2 mg | Sham/ 2 mg | 2 mg | Sham/ 2 mg | |||||||||||||||
CRVO | COPERNICUS 2013 [20,36] | Aflibercept | 1266* | 0.9% (1) | 0 | Nr | Nr | 0 | 1.7% (1) | Nr | ||||||||
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 | 2892* | 0 | 2.3% (3) | 1.6% (2) | 3.9% (5)/ 1.8% (2) | 0 | 0 | 1.6% (2) | 0/ 1.8% (2) | 0 | ||||||
CRVO/ BRVO | HORIZON 2012 [30] | Ranibizumab | 0.9% (2) | 0 | 0 | 0 | Nr | 0 | Nr | |||||||||
BRVO | BRAVO 2011 [23] | Ranibizumab | 2679* | 0 | 0.8% (1) | 0 | 2.2% (3) | 0 | 3.1% (4)/ 0.9% (1) | 0.7% (1) | 0 | 0 | 0.7% (1) | 0 | 0 | 0 | ||
BRVO/ CRVO | HORIZON 2012 [30] | Ranibizumab | 0 | 0 | Nr | 0 | Nr | |||||||||||
1 mg | 4 mg | Grid | 1 mg | 4 mg | Grid | |||||||||||||
BRVO | SCORE 2009, 2011 [5,32] | Triamcinolone | 914 | 0 | 0.1% (1) | 0 | Nr | 0.7% (1) | 0 | 0.7% (1) | Nr | Nr | ||||||
BRVO | Parodi 2008 [27] | Triamcinolone | 11 | 0 | 0 | 0 | Nr | 0 | ||||||||||
1.25 mg | Grid | |||||||||||||||||
BRVO | Russo 2009 [28] | Bevacizumab | 25 | 0 | 0 | 0 | Nr | Nr | Nr | |||||||||
BRVO | Donati 2012 [29] | Bevacizumab | 63* | Nr | Nr | Nr | Nr | Nr |
Nr: Not reported
* Result of calculation as follows: median number of intravitreal injection multiplicated by number of participants per group
# Number of implants by dosing groups: 1342 0.7 mg, 373 0.35 mg