跳至主要内容
临床试验/NCT00800995
NCT00800995已完成3 期

SOD as Antioxidant Treatment OF ARMD

Centre de Recherche en Nutrition Humaine Rhone-Alpe2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2005年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
difference on AREDS score, Month 24 - Month 0

研究概览

简要总结

INTRODUCTION:

Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms.

Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral neo-vascular ARMD

排除标准

  • other pathology

结局指标

主要结局

difference on AREDS score, Month 24 - Month 0

时间窗: 24 months

次要结局

未报告次要终点

研究者

发起方
Centre de Recherche en Nutrition Humaine Rhone-Alpe
申办方类型
Other

研究点 (2)

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