Table 16

Safety data in trials assessing more than one drug

Ahmadieh31ATEMD 2011 (Oliveira Neto et al)56DRCR Network 2010 (Elman et al, )2146Lim et al55Soheilian et al3741
Number of patients
Ocular adverse events
 Mild anterior chamber reactionIVB: 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 treatmentNRNRNRIVB: 20% (n=10 eyes), resolved after 1 week; IVB/IVT: 18% (n=9 eyes), resolved after 1 week
 Marked anterior chamber reactionIVB: n=1 (topical corticosteroid and cycloplegic drops)NRNRNRIVB: n=1 (topical corticosteroids and cycloplegic drops);
 Progression of fibrous proliferationIVB: n=1 with no sign of retinal tractionNRNRNRIVB: n=1 with no sign of retinal traction;
 Vitreous haemorrhageIVB/IVT: n=1 after third injection (excluded from study)NRNRNRNR
 IOP riseIVB: 23, 22 and 28 mm Hg at 6, 12 and 18 weeks (anti-glaucoma drops)NRIOP elevation more frequent with triamcinolone + PLIVB/IVT: 8.3%
IVT: 10.8%
 IOP ≥10 mm Hg from baselineNRNRCPL: n=16; RPL: n=10; RDL: n=5; TPL: n=70NRNR
 IOP ≥30 mm Hg from baselineNRNRCPL: n=3; RPL: n=2; RDL: n=4; TPL: n=46NRNR
 Initiation of IOP lowering treatment at any visitNRNRCPL: n=9; RPL: n=5; RDL: n=4; TPL: n=41NRNR
 Iris neovascularisationNoneNRNRNRNR
 Lens opactiyNoneNRNRNRSevere lens opacity IVB/IVT: n=4 eyes; MPC: n=1 eye
 EndophthalmitisNRNRCPL: n=1; RPL: n=1; RDL: n=1; TPL: n=0NRNone
 PseudoendophthalmitisNRNRCPL: n=1; RPL: n=0; RDL: n=0; TPL: n=1NRNR
 Ocular vascular eventNRNRCPL: n=1; RPL: n=1; RDL: n=0; TPL: n=2NRNR
 Retinal detachmentNRNRCPL: n=0; RPL: n=0; RDL: n=1; TPL: n=0NRNone
 VitrectomyNRNRCPL: n=7; RPL: n=0; RDL: n=3; TPL: n=0NRNR
 Vitreous haemorrhageNRNRCPL: n=15; RPL: n=3; RDL: n=4; TPL: n=2NRNone
 Cataract surgeryNRNRCPL: 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)NRNR
 Glaucoma surgeryNRNRNRNRNR
 Retinal neovascularisationNRNRNRNRIVB: n=4 (all resolved); MPC: n=3 eyes (2 resolved)
 Development of early PDRNRNRNRNRIVB: n=1; IVB/IVT: n=4; MPC: n=3
 Progression to high-risk PDRNRNRNRNRIVB: n=4; IVB/IVT: n=3; MP: n=3
 Ocular hypertension (≥23 mm HG)NRNRNRNRIVB/IVT: 16% (n=8 of eyes), controlled medically in all except 1 that progressed to neovascular glaucoma
Systemic adverse events
 Acute myocardial infarctionN=1, considered not to be related to the study drugNo specific systemic adverse events that could be attributed to chanceNo significant blood pressure increase, no thromboembolic events
 DeathsC: n=1N=1, considered not to be related to the study drugCPL: n=8; RPL: n=5; RDL: n=3; TPL: n=2IVB/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.