MaculopathyNCT06351033
Ozonized Oil as Dietary Supplement in Macular Degeneration
An observational study of Maculopathy, run by Alba Di Pardo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Maculopathy
- What is being tested?
- High ozonide (HOO) ozonated oil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Inability to understand informed consent and the purpose of the study
- Women who are pregnant or who may become pregnant during treatment
Who cannot join
- 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)
Show all 9Show fewer
- Glaucoma
- Oncological diseases
- Liver and kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration
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.
Read more
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.
Read the 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
- Being tested
- High ozonide (HOO) ozonated oil
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High ozonide (HOO) ozonated oilDietary supplement
ozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: High ozonide (HOO) ozonated oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of any slowing down of the maculopathy
field of view
Measured: 3 months from the beginning of the ozonated oil administration
evaluation of any slowing down of the maculopathy
field of view
Measured: 6 months from the beginning of the ozonated oil administration
evaluation of any slowing down of the maculopathy
field of view
Measured: 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
Measured: 12 months from the beginning of the ozonated oil administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start31 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MaculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alba Di Pardo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alba Di Pardo, Neuromed IRCCS
- Investigators
- Eliana Palermo, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351033
- Sponsor's protocol ID
- ADP_012023
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration
- ClinicalTrials.gov ID
- NCT06351033
- Acronym / sponsor ID
- ADP_012023
- Conditions
- Maculopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alba Di PardoUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Dietary Supplement: High ozonide (HOO) ozonated oilOzonized 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Inability to understand informed consent and the purpose of the study
- Women who are pregnant or who may become pregnant during treatment
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High ozonide (HOO) ozonated oilozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules | Dietary supplement | Ozonized Oil |
Primary outcome
evaluation of any slowing down of the maculopathy
Time frame: 3 months from the beginning of the ozonated oil administration
field of view
evaluation of any slowing down of the maculopathy
Time frame: 6 months from the beginning of the ozonated oil administration
field of view
evaluation of any slowing down of the maculopathy
Time frame: 9 months from the beginning of the ozonated oil administration
field of view
evaluation of any slowing down of the maculopathy and closure of the study
Time frame: 12 months from the beginning of the ozonated oil administration
field of view
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliana Palermo principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maculopathy, run by Alba Di Pardo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of any slowing down of the maculopathy (time frame: 3 months from the beginning of the ozonated oil administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.