Clinical Study

Fixed Monthly versus Less Frequent Ranibizumab Dosing and Predictors of Visual Response in Exudative Age-Related Macular Degeneration

Table 1

Clinical trial designs.

Fixed monthly dosing regimenLess than monthly dosing regimen after three monthly loading doses

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

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

CNV: choroidal neovascularization; OCT: optical coherence tomography; PDT: photodynamic therapy; VA: visual acuity.
aFor SAILOR, only cohort 1 treatment-naïve patients were included in this analysis. This ensured that the patient population was most similar to the ANCHOR, MARINA, and PIER trials, and that all clinical trials included in this analysis began with three monthly loading doses as part of their dosing schedules.