MAY 13, 2011
This double-masked, multicenter study was the first prospective trial to directly compare monthly and quarterly ranibizumab dosing regimens in the treatment of patients with subfoveal choroidal neovascularization (CNV) secondary to AMD. It found the monthly regimen to be superior.
It included 304 patients with subfoveal CNV secondary to AMD randomized to quarterly (0.3 or 0.5 mg) or monthly (0.3 mg) doses of ranibizumab. A loading dose of three consecutive monthly injections was followed by a nine-month maintenance phase of either monthly or quarterly injections.
At month 12, BCVA gain was significantly higher in the monthly group, 8.3 letters compared with 3.8 and 4.9 letters in the quarterly groups. The proportion of patients who lost <15 letters from baseline to month 12 was similar across the treatment groups. The proportion of patients who had a VA gain of ≥15 letters from baseline to month 12 was 14.2 percent in the 0.3 mg quarterly group, 17.8 percent in the 0.5 mg quarterly group, and 28.7 percent in the 0.3 mg monthly group
Mean change in central retinal thickness from baseline to month 12 was -96.0 μm in 0.3 mg quarterly, -105.6 μm in 0.5 mg quarterly, and -105.3 μm in 0.3 mg monthly group.
The authors conclude that this data is consistent with the clinical guidance on ranibizumab treatment, which recommends rigorous monthly monitoring with timely retreatment of patients with recurrent disease.