Table 10

Bevacizumab safety

BOLT study2352Lam et al35Faghihi et al53
Number of patientsMLT: n=38; IVB: n=42IVB1.25, n=26; IVB2.5, n=26IVB1.25 n=40 IVB 1.25 plus MLT n=40
Ocular adverse eventsNot reported
 Loss of _15 or _30 ETDRS lettersMLT: n=1 transient, 3 at 24 month analysis; IVB: n=4 transientNo significant ocular events (IOP increase, retinal tear, retinal detachment, endophthalmitis); no significant difference in change in cataract scores between groups
 Vitreous haemorrhageMLT: n=1; IVB: n=0
 Eye pain/irritation/watering during or after injectionMLT:n=0; IVB: n=8
 Red eye after injectionMLT: n=0; IVB: n=8
 EndophthalmitisNR
 Transient IOP increase≥30 mm Hg—MLT: 0; IVB: n=4≥45 mm Hg—MLT: n=1; IVB: n=1
 Floaters after injectionMLT: n=0; IVB: n=2
 Corneal epithelial defectMLT:n=0; IVB:n=1
 Vitreomacular traction with macular oedemaMLT: n=1; IVB: n=0
Systematic adverse events
 AnaemiaMLT: n=1; IVB: n=0No systematic adverse effects (1 patient in 1.25 mg group with foot gangrene requiring amputation due to worsening diabetic neuropathy, considered unrelated to treatment)
 Vomiting after FFAMLT: n=1; IVB: n=0
 Uncontrolled hypertensionMLT:n=0; IVB: n=1
 Polymyalgia rheumaticaMLT:n=0; IVB: n=1
 Intermittent claudicationMLT:n=0; IVB: n=1
 GastroenteritisMLT:n=0; IVB: n=1
 FallMLT:n=2; IVB: n=0
 Urinary tract infectionMLT:n=0; IVB: n=1
 Chest infectionMLT:n=0; IVB: n=1
 Headaches, dizziness, tirednessMLT:n=1; IVB: n=0
 Bell palsyMLT:n=1; IVB: n=0
 Admission for diabetic foot ulcerMLT:n=1; IVB: n=1
 Admission for cholecystectomyMLT:n=0; IVB: n=1
 Admission for fall/loss of consciousnessMLT:n=1; IVB: n=0
 Angina—hospital admissionMLT:n=1; IVB: n=0
 Cerebrovascular accidentMLT:n=1; IVB: n=0
 Myocardial infarctionMLT:n=0; IVB: n=2
 Coronary artery bypass graftMLT:n=0; IVB: n=1
 Dyspnea, chest pain–admitted for hospital observationMLT:n=0; IVB: n=1
DeathNR
  • ETDRS, Early Treatment Diabetic Retinopathy Study; FFA, fundus fluorescein; IOP, intraocular pressure; IVB, intravitreal bevacizumab; MLT, macular laser therapy; NR, not reported.