[Translation] A multicenter, randomized, double-blind, placebo-controlled, parallel-controlled clinical study to evaluate the efficacy and safety of idebenone tablets in the treatment of visual impairment in patients with Leber’s hereditary optic neuropathy (LHON)
主要目的:评估艾地苯醌片用于治疗Leber’s遗传性视神经病变(LHON)患者的视觉障碍的临床有效性(与安慰剂相比)。临床有效性的评价基于第52周BCVA与基线相比达到CRR(即,与基线相比,视标内BCVA改善≥0.2 logMAR,视标外BCVA≤1.6 logMAR)的受试者比例。
次要目的:评估艾地苯醌在Leber’s遗传性视神经病变(LHON)患者中的安全性。
[Translation] Primary objective: To evaluate the clinical effectiveness of idebenone tablets (compared with placebo) for the treatment of visual impairment in patients with Leber’s hereditary optic neuropathy (LHON). Clinical effectiveness was evaluated based on the proportion of subjects achieving CRR (i.e., BCVA improvement ≥0.2 logMAR within the visual mark and BCVA ≤1.6 logMAR outside the visual mark compared with baseline) at Week 52.
Secondary objective: To evaluate the safety of idebenone in patients with Leber’s hereditary optic neuropathy (LHON).