A 12-week, randomized, double-blind, placebo-controlled study assessing the efficacy of EGHB010, a standardized extract of Paeoniae radix and Glycyrrhizae radix, in patients with early age-related macular degeneration

Abstract

Background: EGHB010, a standardized extract of Paeoniae radix and Glycyrrhizae radix, inhibits choroidal neovascularization. The aim of this study is to evaluate the efficacy and safety of EGHB010 on early agerelated macular degeneration (AMD) progression inhibition. Methods:The study was designed as a randomized, double-blind, single-center, placebo-controlled study.Subjects were 50 years of age or older, and early AMD satisfied the criteria of more than 15 small (<63 µm) drusen, less than 20 intermediate (≥63, <125 µm) drusen, or pigment abnormalities. For 12 weeks, the treatment group received EGHB010 and the control received the placebo. The main outcomes were changes in macular pigment optical density (MPOD), central macular thickness (CMT), and central choroidal thickness (CCT). Subgroup analysis was performed on subjects with MPOD <0.75 at baseline.Results: Forty-eight subjects out of 94 were assigned to the treatment group, and 46 to the control group.At 12 weeks, mean MPOD of the treatment group increased by 0.04±0.27 (P=0.2730), and that of the control group decreased by 0.03±0.21 (P=0.7240), but there was no significant difference between the two groups (P=0.1234). There were no significant differences between the two groups in mean CMT and CCT (P=0.6718 and 0.6608, respectively). In subgroup analysis, there were 39 subjects with MPOD <0.75 in the treatment group and 36 in the control. Mean MPOD of the treatment group significantly increased by 0.09±0.25 (P=0.0218), and there was a significant difference in mean MPOD at 12 weeks between the two groups (P=0.0248). Adverse reactions were similar in both groups, and no subjects had serious adverse events.Conclusions: EGHB010 is expected to increase MPOD when administered to subjects with MPOD <0.75. EGHB010 is worth considering as a substance that inhibits the progression of early AMD.