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Ivan J. Suner, Linda Yau, Phil Lai; HARBOR Study: One-Year Results of Efficacy and Safety of 2.0 mg versus 0.5 mg Ranibizumab in Patients with Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3677.
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Evaluate efficacy and safety of 2.0 mg versus 0.5 mg ranibizumab in patients with subfoveal neovascularization secondary to age-related macular degeneration (wet AMD).
Patients ≥50 years of age with subfoveal wet AMD (n=1097) were randomized to receive 2.0 mg or 0.5 mg ranibizumab intravitreal injections dosed monthly or on an as-needed (PRN) basis after three loading doses. 12-month primary endpoint analyses were performed using last observation carried forward to impute for missing data.
At Month 12, mean change from baseline in best-corrected visual acuity (BCVA) for the four treatment groups (mean number of ranibizumab injections) was: 0.5 monthly, +10.1 letters (11.3 injections); 2.0 monthly, +9.2 letters (11.2 injections); 0.5 PRN, +8.2 letters (7.7 injections); 2.0 mg PRN, +8.6 letters (6.9 injections). The proportion of patients who lost <15 letters from baseline at Month 12 was 97.8%, 93.4%, 94.5%, and 94.9%, respectively. Mean change from baseline in central foveal thickness was -172.0 μm, -163.3 μm, -161.2 μm, and -172.4 μm, respectively. The incidence of ocular and nonocular adverse events (AEs) and serious AEs were consistent with previous ranibizumab trials in AMD and were comparable between groups.
The one-year results of the HARBOR Study demonstrated excellent and clinically meaningful improvement in visual acuity and anatomic outcomes across all four treatment groups. Through Month 12, superiority of ranibizumab 2.0 mg monthly over ranibizumab 0.5 mg monthly was not demonstrated by the mean change from baseline in BCVA, and the PRN groups did not met the prespecified noninferiority criteria (margin of 4 letters) to ranibizumab 0.5 mg monthly. The proportion of patients who lost <15 letters at Month 12 from baseline were similar in the 0.5 mg PRN and monthly groups. No new safety signals were observed.
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