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Ozonized Oil as Dietary Supplement in Macular Degeneration

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06351033
Enrollment
60
Registered
2024-04-08
Start date
2023-10-31
Completion date
2024-12-31
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maculopathy

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.

Interventions

DIETARY_SUPPLEMENTHigh ozonide (HOO) ozonated oil

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

Sponsors

Alba Di Pardo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
evaluation of any slowing down of the maculopathy and closure of the study12 months from the beginning of the ozonated oil administrationfield of view
evaluation of any slowing down of the maculopathy3 months from the beginning of the ozonated oil administrationfield of view

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026