Ozonized Oil as Dietary Supplement in Macular Degeneration

Maculopathy Clinical Trial

Official title:

Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06351033
• Other study ID #: ADP_012023
• Status: Active, not recruiting
• Start date: October 31, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Neuromed IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Definite AMD diagnosis with documented disease progression within the past 6 months

• Age: 50-85 years old

• Ascertained differential diagnosis with the aid of diagnostic tools: fundus examination eye; analysis of the macular region using optical computed tomography (OCT)

Exclusion Criteria:

• 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)

• Glaucoma

• 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

Related Conditions & MeSH terms

• Macular Degeneration
• Maculopathy

Intervention

Dietary Supplement:
• High ozonide (HOO) ozonated oil
ozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules

Locations

Country	Name	City	State
Italy	IRCCS Neuromed	Pozzilli

Sponsors (1)

Lead Sponsor	Collaborator
Alba Di Pardo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of any slowing down of the maculopathy	field of view	3 months from the beginning of the ozonated oil administration
Primary	evaluation of any slowing down of the maculopathy	field of view	6 months from the beginning of the ozonated oil administration
Primary	evaluation of any slowing down of the maculopathy	field of view	9 months from the beginning of the ozonated oil administration
Primary	evaluation of any slowing down of the maculopathy and closure of the study	field of view	12 months from the beginning of the ozonated oil administration