MYRROR 2010.
Methods |
Study design: parallel group randomised controlled trial. Unit of randomisation and analysis: the participant (1 study eye per participant). The criteria for eye selection were not reported. |
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Participants |
Country: Asia (Hong Kong, Japan, Republic of Korea, Singapore and Taiwan) Setting: international, multicentre (see appendix of MYRROR 2010) Number of participants: 122 (only 121 participants were included in the full analysis set) Number of men: 29 Number of women: 92 Age (mean ± SD): 58.2 ± 13.3 years Ethnic group: Asian Inclusion criteria:
Exclusion criteria:
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Interventions |
Intervention: intravitreal aflibercept 2.0 mg, retreatment afterwards in case CNV persisted or recurred (based on predefined criteria) at monthly follow‐up through week 44. If the assessment for retreatment was negative, participants were given sham injections for masking purpose (90 participants). Comparator: sham injections every month through to week 20. Intravitreal aflibercept 2.0 mg at week 24 and retreatment afterwards in case CNV persisted or recurred at monthly follow‐up from week 28 to week 44 (same treatment regimen as the intervention group) (31 participants). |
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Outcomes |
Primary outcomes:
Secondary outcomes:
Follow‐up: 48 weeks VA measurement: ETDRS chart at a distance of 4 m. |
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Notes |
Date conducted: November 2010 to August 2013 Sources of funding: Bayer HealthCare Pharmaceuticals, Leverkusen, Germany Declaration of interest: "The authors take full responsibility for the scope, direction, and content of the manuscript, and have approved the submitted manuscript." Financial interests were not reported. Trial registration: NCT01249664 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "MYRROR was an international, phase III, multicenter, randomised, double‐masked, sham‐controlled study." "patients received sham injections only for masking purposes." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "MYRROR was an international, phase III, multicenter, randomised, double‐masked, sham‐controlled study." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "In total, 122 patients were randomised, of whom 91 received intravitreal aflibercept 2.0 mg and 31 received sham; 122 patients were included in the safety set. In the full analysis set, 121 patients were included (90 patients received intravitreal aflibercept 2.0 mg and 31 received sham)." Comment: according to participant flow data on ClinicalTrials.gov, 5 participants were withdrawn from the study and 1 participant did not complete visits to week 48 due to adverse events, both in the aflibercept group. However, only 1 participant failed to fulfil requirements of full analysis set after randomisation. |
Selective reporting (reporting bias) | Low risk | Comment: the outcome measures were prespecified on ClinicalTrials.gov registration. Though some outcomes (e.g. the proportion of participants losing ≥ 5, 10 or 15 letters) were not reported in the manuscript, data were shown in the "study results" section on ClinicalTrials.gov website. |
Other bias | Low risk | Comment: no other bias identified. |