Iacono 2012.
Methods |
Study design: parallel group randomised controlled trial. Unit of randomisation and analysis: the participant (1 study eye per participant). It was not reported how the eye was chosen. |
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Participants |
Country: Italy Setting: Department of Ophthalmology of the Vita‐Salute University of Milan, Italy Number of participants: 55 Number of men: 13 Number of women: 42 Age (mean ± SD): 65 ± 12 years in the ranibizumab group and 61 ± 11 years in the bevacizumab group. Ethnic group: not reported Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention: intravitreal ranibizumab 0.50 mg, retreatment afterwards based on FA or OCT changes every month (27 participants) Comparator: intravitreal bevacizumab 1.25 mg, retreatment afterwards based on FA or OCT changes every month (28 participants) |
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Outcomes |
Primary outcomes:
Secondary outcomes:
Follow‐up: 18 months VA measurement: ETDRS chart at a distance of 4 m. |
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Notes |
Date conducted: participants enrolled from April 2006 to July 2007, and followed for 18 months. Sources of funding: not reported Declaration of interest: F Bandello is an advisory board member for Novartis Pharma. The other authors had no proprietary or financial interest in any of the products mentioned in the study. Trial registration: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The patient randomisation to either IVR [intravitreal ranibizumab] or IVB [intravitreal bevacizumab] was performed by means of sequentially numbered envelopes according to a computer‐generated code list. A permuted block randomisation was performed with a final allocation ratio of 1:1." |
Allocation concealment (selection bias) | Low risk | Quote: "by means of sequentially numbered envelopes according to a computer‐generated code list and stored by an investigator, unaware of the purpose of the study." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "by an experienced retinologist masked to the type of injection." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Best‐corrected visual acuity measurements were made at each visit by an expert examiner, unaware of the purpose of the study, whereas FA and OCT were interpreted separately by two experienced ophthalmologists masked to each other." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "after randomisation and before the administration of the first injection, four patients in the IVR group and three patients in the IVB group refused to participate in the study because they were unable to follow the strict study protocol." Comment: the reason for withdrawal was reported and balanced across arms. |
Selective reporting (reporting bias) | Low risk | Comment: protocol could not be found but outcome measures were specified in the methods section. |
Other bias | Low risk | Comment: no other bias identified. |