Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- evaluation of any slowing down of the maculopathy and closure of the study
研究概览
简要总结
Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.
AMD is a disease with a multifactorial etiology. The main factors which, associated with the genetic ones, increase the risk of WMD onset are represented by smoking, obesity, hypertension, cardio-vascular diseases, a diet rich in dietary fat and alcohol intake. From an organic point of view, AMD is a disease that affects the macular region of the retina, causing progressive loss of central vision.
Retinal cells are characterized by high oxygen consumption. Reactive oxygen species (ROS), such as superoxide anion, hydrogen peroxide and hydroxyl radical are the standard product of cellular metabolism within the mitochondria. Under physiological conditions, ROS are neutralized by a system of antioxidants. In case of cellular metabolism disturbances or insufficiency of the antioxidant system, an excess of ROS can be produced which contributes to oxidative stress, widely described as exerting deleterious effects on cells. The high oxygen requirement and low levels of antioxidant enzymes make the retina extremely sensitive to oxidative stress and more susceptible to cell death. Prevention of neuronal death in the retina becomes a crucial aspect for the management of WMD.
The treatment of choice for AMD today is the use of anti-VEGF (Vascular Endothelial Growth Factor) drugs, they are effective for neo-vascular AMD, acting on the inhibition of the angiogenic protein VEGF, which is produced in the retina and induced by hypoxia and other conditions. It is practice, however, to support the integration of nutritional supplements such as zinc, resveratrol, carotenoids such as lutein and zeaxanthin, vitamin E and Omega-3 fatty acids.
The aim of this study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration in the possible slowing of disease progression.
详细描述
The aim of the study is to evaluate the efficacy of ozonated oil with high ozonides (HOO) administered orally as gastro-resistant capsules (O3Zone, GS Pharma, Malta), as an integrative and complementary treatment in patients affected by macular degeneration.
Field of view will be monitored to reveal the possible slowing of disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Psychiatric diseases
- •Type I and II diabetes
- •Patients with high refractive defects: myopia > 6 d; hyperopia > 4 d; astigmatism > 4 d
- •Corneal pathologies
- •Hereditary retinal diseases
- •Autoimmune diseases (uveitis)
- •Oncological diseases
- •Liver and kidney disease
- •Inclusion in other clinical trials
- •Inability to understand informed consent and the purpose of the study
- •Women who are pregnant or who may become pregnant during treatment
结局指标
主要结局
evaluation of any slowing down of the maculopathy and closure of the study
时间窗: 12 months from the beginning of the ozonated oil administration
field of view
evaluation of any slowing down of the maculopathy
时间窗: 9 months from the beginning of the ozonated oil administration
field of view
次要结局
未报告次要终点
研究者
Alba Di Pardo
PhD
Neuromed IRCCS
