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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
At 12 weeks from baseline, the mean macular pigment optical density (MPOD) of the treatment group increased by 0.04 ± 0.27 (p-value = 0.2730) and that of the control group decreased by 0.03 ± 0.21 (p-value = 0.7240). The mean MPOD was 0.61 ± 0.22 in the treatment group and 0.56 ± 0.21 in the control group, and there was no statistically significant difference between the two groups (p-value = 0.1234). The mean central macular thickness (CMT) of the treatment group increased by 15.08 ± 19.26 µm (p-value <0.0001) and that of the control group increased by 11.59 ± 23.98 µm (p-value = 0.0033). The mean CMT was 258.19 ± 22.28 µm in the treatment group and 260.37 ± 27.26 µm in the control group, and there was no statistically significant difference between the two groups (p-value = 0.6718). The mean central choroidal thickness (CCT) of the treatment group increased by 19.50 ± 46.54 µm (p-value = 0.0056) and that of the control group increased by 10.20 ± 39.02 µm (p-value = 0.0831). The mean CCT was 222.25 ± 55.50 µm in the treatment group and 227.76 ± 65.64 µm in the control group, and there was no statistically significant difference between the two groups (p-value = 0.6608). A-wave amplitude, B-wave amplitude, and implicit time of ERG were not significantly different from baseline at 12 weeks in both groups, and the difference between the two groups was not statistically significant (p-value = 0.6056, 0.9849, and 0.4042, respectively). In subgroup analysis, there were 39 subjects with MPOD <0.75 in the treatment group and 36 in the control. At 12 weeks from baseline, the mean MPOD of the treatment group statistically increased by 0.09 ± 0.25 (p-value = 0.0218), and that of the control group increased by 0.02 ± 0.16 (p-value = 0.5605). The mean MPOD was 0.61 ± 0.21 in the treatment group and 0.52 ± 0.17 in the control group and significantly different (p-value = 0.0248).
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •The participants in this study were early Age-related macular degeneration (AMD) satisfying the criteria of AREDS Category 2. The study was limited to those with no significant macular abnormalities affecting visual acuity. If both eyes met the criteria, the worse side was registered.
排除标准
- •Those with a central macular thickness (CMT) greater than 300 µm, higher than severe nonproliferative diabetic retinopathy, a history of infectious ocular disease, or a high risk of developing exudative AMD such as large pigment epithelial detachment, retinal hemorrhage, or GA were excluded. In addition, those with systemic diseases such as malignant tumors, renal dysfunction, liver dysfunction, electrolyte abnormalities, uncontrolled hypertension, uncontrolled diabetes, infectious diseases, and cardiopulmonary diseases and those who had taken medicines or health functional foods that might have affected this study within the last 4 weeks were excluded. Prohibited concomitant drugs were retinal (an active aldehyde form of vitamin A), lutein, zeaxanthin, omega 3, beta-carotene, astaxanthin, anthocyanin, and multivitamins.