Phase III study: Twelve-Month comparison of 0.5 mg or 2.0 mg ranibizumab in patients with wet age-related macular degeneration (HARBOR)
Source: Ophthalmology
Area: News
Several small studies have suggested the potential of enhanced efficacy with higher 2mg dosing of ranibizumab. The HARBOR study was a 24-month, phase III, randomised, multicentre, double-masked study which evaluated the 12-month efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg administered monthly and on an as-needed (PRN) basis in treatment-naïve patients (n=1,098) aged over 50 years with subfoveal neovascular age-related macular degeneration (wet AMD).
Noninferiority (NI) tests with a prespecified NI margin of 4 letters comparing the 0.5 mg PRN with the 0.5 mg monthly group and the 2.0 mg PRN with the 0.5 mg monthly group were performed. A superiority test assessed the differences between the 2.0 mg monthly and 0.5 mg monthly groups.
The following results were reported:
. The primary efficacy end point, the mean change from baseline in best-corrected visual acuity (BCVA) at month 12, was +10.1 letters (0.5 mg ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news
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