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Fixed monthly dosing regimen | Less than monthly dosing regimen after three monthly loading doses |
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ANCHOR [1] | PIER [3] |
(i) Pivotal, phase III, and double masked | (i) Phase IIIb, double masked |
(ii) Predominantly classic CNV | (ii) Minimally classic, predominantly classic, or occult CNV, with or without a classic CNV component |
(iii) Three arms: PDT, ranibizumab 0.3 mg, and ranibizumab 0.5 mg | (iii) Three arms: sham injection controlled, ranibizumab 0.3 mg, and ranibizumab 0.5 mg |
(iv) Option of crossover from PDT cohort to ranibizumab 0.3 mg in second treatment year | (iv) Option of crossover from sham cohort to ranibizumab 0.5 mg followed by option for all cohorts to roll over from quarterly to monthly ranibizumab 0.5 mg dosing in second treatment year |
(v) Dosing: monthly for 2 years | (v) Dosing: three monthly loading doses + quarterly maintenance doses for 2 years |
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MARINA [2] | SAILOR cohort 1 treatment-naïvea [4] |
(i) Pivotal, phase III, double masked | (i) Phase IIIb, single masked |
(ii) Minimally classic or occult without classic CNV | (ii) All CNV subtypes, with evidence of recent disease progression |
(iii) Three arms: sham injection controlled, ranibizumab 0.3 mg, and ranibizumab 0.5 mg | (iii) Two arms: ranibizumab 0.3 mg, ranibizumab 0.5 mg |
(iv) Option of crossover from sham cohort to ranibizumab 0.5 mg late in second treatment year | (iv) Dosing: three monthly loading doses + retreatment as needed (quarterly scheduled monitoring visits) based on VA and/or OCT, for 1 year |
(v) Dosing: monthly for 2 years | |
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