Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-03-14
Brief Title:
Ozonized Oil as Dietary Supplement in Macular Degeneration
Sponsor:
Alba Di Pardo
Organization:
Neuromed IRCCS
Study Overview
Official Title:
Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Field of view will be monitored to reveal the possible slowing of disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None