Clinical trial NCT06351033: Ozonized Oil as Dietary Supplement in Macular Degeneration
Official title: Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Maculopathy
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects participating in the study will be recruited at the Neuro-Ophthalmology Unit of the IRCCS Neuromed according to the selected inclusion and exclusion criteria. They will then be sent to genetic counseling for the reconstruction of the family genealogy, medical history collection and determination of the genetic predisposition to AMD. All recruited individuals will be entered into a database dedicated to the project.

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.

Eligibility 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

Primary outcomes:
measure: evaluation of any slowing down of the maculopathy
timeFrame: 3 months from the beginning of the ozonated oil administration
measure: evaluation of any slowing down of the maculopathy
timeFrame: 6 months from the beginning of the ozonated oil administration
measure: evaluation of any slowing down of the maculopathy
timeFrame: 9 months from the beginning of the ozonated oil administration
measure: evaluation of any slowing down of the maculopathy and closure of the study
timeFrame: 12 months from the beginning of the ozonated oil administration
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: IRCCS Neuromed
name: Eliana Palermo
role: PRINCIPAL_INVESTIGATOR
References: