Ozonized Oil as Dietary Supplement in Macular Degeneration

NCT06351033 | Active Not Recruiting

• 1 other identifier: ADP_012023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Maculopathy

Outcome Measures

Primary Outcomes (4)

• evaluation of any slowing down of the maculopathy

  field of view

  3 months from the beginning of the ozonated oil administration

• evaluation of any slowing down of the maculopathy

  field of view

  6 months from the beginning of the ozonated oil administration

• evaluation of any slowing down of the maculopathy

  field of view

  9 months from the beginning of the ozonated oil administration

• 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

Study Arms (2)

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).

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.

Dietary Supplement: High ozonide (HOO) ozonated oil

Interventions

High ozonide (HOO) ozonated oil DIETARY_SUPPLEMENT

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

Ozonized Oil

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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
• Inability to understand informed consent and the purpose of the study
• Women who are pregnant or who may become pregnant during treatment

Sponsors & Collaborators

• Alba Di Pardo: lead

Study Sites (1)

IRCCS Neuromed

Pozzilli, Italy

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Eliana Palermo

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 8, 2024
• Study Start: October 31, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

IT (1)