Ozonized Oil as Dietary Supplement in Macular Degeneration

NCT ID: NCT06351033

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Maculopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Placebo

Placebo: control group made up of subjects affected by maculopathy - eligible according to the study protocol - subjected to traditional elective treatments only (including intravitreal Anti-VEGF injections).

No interventions assigned to this group

Ozonized Oil

Ozonized Oil: intervention group made up of subjects affected by maculopathy - eligible according to the study protocol - subjected to the traditional treatments of choice (including anti-VEGF intravitreal injections) who receive supplementary treatment with the intake of HOO gastro-resistant capsules.

High ozonide (HOO) ozonated oil

Intervention Type: DIETARY_SUPPLEMENT

ozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules

Interventions

High ozonide (HOO) ozonated oil

ozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alba Di Pardo

OTHER

Sponsor Role: lead

Responsible Party

Alba Di Pardo

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eliana Palermo

Role: PRINCIPAL_INVESTIGATOR

IRCCS Neuromed

Locations

IRCCS Neuromed

Pozzilli, , Italy

Countries

Italy

Other Identifiers

ADP_012023

Identifier Type: -

Identifier Source: org_study_id