Table 16.
Safety data in trials assessing more than one drug
| Ahmadieh31 | ATEMD 2011 (Oliveira Neto et al)56 | DRCR Network 2010 (Elman et al, )21 46 | Lim et al55 | Soheilian et al37 41 | |
|---|---|---|---|---|---|
| Number of patients | |||||
| Ocular adverse events | |||||
| Mild anterior chamber reaction | IVB: 19.5% (n=8 eyes), resolved after 1 week of no treatment; IVB/IVT: 18.9% (n=7 eyes), resolved after 1 week of no treatment | NR | NR | NR | IVB: 20% (n=10 eyes), resolved after 1 week; IVB/IVT: 18% (n=9 eyes), resolved after 1 week |
| Marked anterior chamber reaction | IVB: n=1 (topical corticosteroid and cycloplegic drops) | NR | NR | NR | IVB: n=1 (topical corticosteroids and cycloplegic drops); |
| Progression of fibrous proliferation | IVB: n=1 with no sign of retinal traction | NR | NR | NR | IVB: n=1 with no sign of retinal traction; |
| Vitreous haemorrhage | IVB/IVT: n=1 after third injection (excluded from study) | NR | NR | NR | NR |
| IOP rise | IVB: 23, 22 and 28 mm Hg at 6, 12 and 18 weeks (anti-glaucoma drops) | NR | IOP elevation more frequent with triamcinolone + PL | IVB/IVT: 8.3% IVT: 10.8% |
NR |
| IOP ≥10 mm Hg from baseline | NR | NR | CPL: n=16; RPL: n=10; RDL: n=5; TPL: n=70 | NR | NR |
| IOP ≥30 mm Hg from baseline | NR | NR | CPL: n=3; RPL: n=2; RDL: n=4; TPL: n=46 | NR | NR |
| Initiation of IOP lowering treatment at any visit | NR | NR | CPL: n=9; RPL: n=5; RDL: n=4; TPL: n=41 | NR | NR |
| Iris neovascularisation | None | NR | NR | NR | NR |
| Lens opactiy | None | NR | NR | NR | Severe lens opacity IVB/IVT: n=4 eyes; MPC: n=1 eye |
| Endophthalmitis | NR | NR | CPL: n=1; RPL: n=1; RDL: n=1; TPL: n=0 | NR | None |
| Pseudoendophthalmitis | NR | NR | CPL: n=1; RPL: n=0; RDL: n=0; TPL: n=1 | NR | NR |
| Ocular vascular event | NR | NR | CPL: n=1; RPL: n=1; RDL: n=0; TPL: n=2 | NR | NR |
| Retinal detachment | NR | NR | CPL: n=0; RPL: n=0; RDL: n=1; TPL: n=0 | NR | None |
| Vitrectomy | NR | NR | CPL: n=7; RPL: n=0; RDL: n=3; TPL: n=0 | NR | NR |
| Vitreous haemorrhage | NR | NR | CPL: n=15; RPL: n=3; RDL: n=4; TPL: n=2 | NR | None |
| Cataract surgery | NR | NR | CPL: n=11 (of those phakic at baseline); RPL: n=6 (of those phakic at baseline); RDL: n=8 (of those phakic at baseline); TPL: n=19 (of those phakic at baseline) | NR | NR |
| Glaucoma surgery | NR | NR | NR | NR | NR |
| Retinal neovascularisation | NR | NR | NR | NR | IVB: n=4 (all resolved); MPC: n=3 eyes (2 resolved) |
| Development of early PDR | NR | NR | NR | NR | IVB: n=1; IVB/IVT: n=4; MPC: n=3 |
| Progression to high-risk PDR | NR | NR | NR | NR | IVB: n=4; IVB/IVT: n=3; MP: n=3 |
| Ocular hypertension (≥23 mm HG) | NR | NR | NR | NR | IVB/IVT: 16% (n=8 of eyes), controlled medically in all except 1 that progressed to neovascular glaucoma |
| Systemic adverse events | |||||
| Acute myocardial infarction | N=1, considered not to be related to the study drug | No specific systemic adverse events that could be attributed to chance | No significant blood pressure increase, no thromboembolic events | ||
| Deaths | C: n=1 | N=1, considered not to be related to the study drug | CPL: n=8; RPL: n=5; RDL: n=3; TPL: n=2 | IVB/IVT: n=2; MPC: n=2 | |
C, control; CPL, control plus laser; DMO, diabetic macular oedema; IOP, intraocular pressure; IVB, intravitreal bevacizumab; IVR, intravitreal ranibizumab; IVRL, intravitreal ranibizumab plus laser; IVT, intravitreal triamcinolone; L, laser; NR, not reported; PDR, proliferative diabetic retinopathy; RDL, ranibizumab plus deferred laser; RPL, ranibizumab plus laser; TPL, triamcinoloine plus laser.