Mirshahi 2008.
| Methods | Study design: prospective, randomised, double‐blind clinical trial of intravitreal bevacizumab in PDR Unit of randomisation: eye Unit of analyses: eye Follow‐up: 6 and 16 weeks |
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| Participants | Country: Iran Setting: Eye Research Center, Farabi Eye Hospital, Medical Sciences/University of Tehran Number of participants: 40 (80 eyes) Exclusions post‐randomisation: 0 Losses to follow‐up: 0 Age (median (range)): 52 (39‐68) years Gender: 12 men and 28 women Inclusion criteria: people with high‐risk characteristics identified by Diabetic Retinopathy Study criteria: neovascularisation of the disc ≥ one‐quarter to one/third disc area, any amount of disc neovascularisation with VH or pre‐retinal haemorrhage, or neovascularisation elsewhere ≥ one‐half disc area with VH or pre‐retinal haemorrhage (with or without macular oedema) Exclusion criteria: people with uncontrolled hypertension, recent (in the past 6 months) myocardial infarction or cerebrovascular accident, uncontrolled glaucoma, a history of any type of retinal photocoagulation, a diagnosis of TRD |
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| Interventions | Treatment: intravitreal injection bevacizumab 1.25 mg/0.05 mL at the first session of laser photocoagulation and 3 sessions of laser photocoagulation (1 week apart) Control: sham injection in the fellow eye at the first session of laser photocoagulation and 3 sessions of laser photocoagulation (1 week apart) Duration: only 1 dose |
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| Outcomes | Primary: regression response was defined angiographically Secondary: recurrence of PDR and complications of treatment |
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| Notes | Funding: not reported Trial registration: not reported Date conducted: December 2005 to September 2006 Conflict of interest: none reported This study was designed using both treatments in the same participant: intravitreal bevacizumab in 1 eye compared with PRP in the contralateral eye |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "fellow eyes of each case were randomly assigned to receive Avastin [bevacizumab] or sham" Comment: not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "fellow eye injection was mimicked with a needleless syringe" Comment: personnel were not blinded, but the participants were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "this assessment was carried out by two independent masked observers; in case of conflict it was resolved through discussion" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There were 0 losses |
| Selective reporting (reporting bias) | Low risk | Comment: the results of the variables were described in the methods section |