Parodi 2010.
Methods |
Study design: parallel group randomised controlled trial. Unit of randomisation and analysis: the participant (one study eye per participant). The criteria for eye selection were not reported. |
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Participants |
Country: Italy Setting: Department of Ophthalmology at the University of Udine and University of Trieste Number of participants: 54 Number of men: 17 Number of women: 37 Age (mean): 50.8 years in the bevacizumab group, 48.1 years in the PDT group and 44.5 years in the laser treatment group Ethnic group: not reported Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention: intravitreal bevacizumab 1.25 mg, retreatment afterwards based on OCT or FA changes (19 participants) Comparator 1: PDT with verteporfin (following the Verteporfin in Photodynamic Therapy Study Group guidelines) (18 participants) Comparator 2: krypton laser photocoagulation, eyes developed recurrent CNV with subfoveal location during follow‐up could be retreated using PDT (17 participants) |
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Outcomes |
Primary outcome:
Secondary outcomes:
Follow‐up: 24 months VA measurement: ETDRS chart at a distance of 4 m. |
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Notes |
Date conducted: participants enrolled from January 2006 to July 2006, and followed for 2 years Sources of funding: not reported Declaration of interest: not reported 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: "Each patient was randomly allocated to 1 of the 3 treatment groups through a computer‐generated number." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "At each scheduled examination, a complete ophthalmological assessment was carried out by an investigator who had had no previous contact with the subject and was unaware of the treatment previously administered." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no loss to follow‐up. |
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. |