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David Faber, Zhengrong Li, Phillip Lai, ; Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Wet Age-Related Macular Degeneration: HARBOR 2-Year Results. Invest. Ophthalmol. Vis. Sci. 2013;54(15):6308.
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HARBOR was a 24-month, phase III, randomized, multicenter, double-masked, dose-response study that evaluated the efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered on a monthly or as-needed (PRN) basis after 3 monthly loading doses in treatment-naïve patients with subfoveal neovascular age-related macular degeneration (wet AMD).
Patients (n=1097) aged ≥50 years were randomized in a 1:1:1:1 ratio to 1 of 4 ranibizumab treatment groups: 0.5 mg monthly (n=275); 0.5 mg PRN (n=275); 2.0 mg monthly (n=274) and 2.0 mg PRN (n=273). The primary efficacy endpoint was the mean change from baseline in best-corrected visual acuity (BCVA) at Month 12. Key secondary endpoints included mean change from baseline in BCVA at Month 24, mean number of ranibizumab injections, mean change from baseline in central foveal thickness (CFT) over time, and the proportion of patients who gained ≥15 letters in BCVA. Ocular and systemic safety events were also evaluated through Month 24.
At Month 24, the mean change from baseline in BCVA was (letters): +9.1 (0.5 mg monthly), +7.9 (0.5 mg PRN), +8.0 (2.0 mg monthly), and +7.6 (2.0 mg PRN), respectively. The change in mean BCVA from Month 12 to 24 was (letters): -1.0, -0.3, -1.2, and -1.0, respectively. The mean number of injections during Year 2 was 5.6 (0.5 mg PRN) and 4.3 (2.0 mg PRN). Mean change from baseline in CFT at Month 24 was (μm): -182.5 (0.5 mg monthly), -172.0 (0.5 mg PRN), -171.8 (2.0 mg monthly), and -181.0 (2.0 mg PRN), respectively. The proportion of patients who gained ≥15 letters from baseline in BCVA through Month 24 was (%): 34.5 (0.5mg monthly), 33.1 (0.5 mg PRN), 37.6 (2.0 mg monthly), and 34.8 (2.0 mg PRN), respectively. Ocular and systemic safety profile in year 2 was similar between all 4 treatment groups, and was consistent with previous ranibizumab trials in AMD.
At Month 24, mean BCVA improvements were significant and clinically meaningful for all 4 treatment groups. The 0.5 mg PRN group achieved a mean gain of 7.9 letters at Month 24 with an average of 13.3 injections over 2 years (5.6 injections in Year 2). No new safety events were identified.
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