Prospective, Open, Comparative, Randomized Study of the Efficacy and Safety Evaluation of the Mexidol® Sequential Therapy of Patients With Primary Open-angle Glaucoma (POAG)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmasoft
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Degree of expression of mitochondrial dysfunction
研究概览
简要总结
Hypothesis: The use of neurocytoprotectors helps restore the functional activity of mitochondria, improve the nervous activity of the retina and optic nerve, and stabilize the glaucomatous process.
详细描述
Hypothesis
Mexidol® allows to optimize POAG therapy by reducing mitochondrial dysfunction and stabilizing glaucomatous optic neuropathy by improving the functional activity of mitochondria and its energy-producing function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An advanced stage of POAG in one or two eyes
- •Hypotonic-compensated intraocular pressure (IOP)
排除标准
- •Degenerative diseases of the central nervous system, diabetes mellitus
- •Primary mitochondrial dysfunction
- •A history of surgical interventions and damage to the organ of vision
- •Acute or chronic inflammatory or hereditary degenerative eye diseases (anterior and posterior sections)
- •Decompensation of concomitant somatic diseases
- •Taking antioxidants/nootropic drugs 6 months before inclusion in the study
- •Hypersensitivity to ethylmethylhydroxypyridine succinate or to any of the excipients
研究组 & 干预措施
Main (Mexidol and standard therapy)
Mexidol IM 300 mg for 14 days, then Mexidol FORTE 250 orally 250 mg 1 tablet 3 times a day for 8 weeks; IOP normalizing therapy
干预措施: Mexidol (Drug)
结局指标
主要结局
Degree of expression of mitochondrial dysfunction
时间窗: 90 days
Enzyme status of lymphocytes (Succinate dehydrogenase and Glycerophosphate dehydrogenase)
Dynamics of the structural and functional characteristics of mitochondria
时间窗: 90 days
Cytomorphodensitometry (number of mitochondria, their optical density, number of granules and deposits in the mitochondria of lymphocytes)
次要结局
- Structural and topographic changes in the layer of nerve fibers and the retinal ganglion [Optical Coherence Tomography (OCT) parameters](90 days)
- Аssessment of differential light sensitivity of the retina(90 days)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](90 days)