Skip to main content
. 2014 Nov 24;2014(11):CD008721. doi: 10.1002/14651858.CD008721.pub2

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
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
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
Outcomes Primary: regression response was defined angiographically
Secondary: recurrence of PDR and complications of treatment
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
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