Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT06351033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ozonized Oil as Dietary Supplement in Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of any slowing down of the maculopathy', 'timeFrame': '3 months from the beginning of the ozonated oil administration', 'description': 'field of view'}, {'measure': 'evaluation of any slowing down of the maculopathy', 'timeFrame': '6 months from the beginning of the ozonated oil administration', 'description': 'field of view'}, {'measure': 'evaluation of any slowing down of the maculopathy', 'timeFrame': '9 months from the beginning of the ozonated oil administration', 'description': 'field of view'}, {'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', 'description': 'field of view'}]}, 'conditionsModule': {'conditions': ['Maculopathy']}, 'descriptionModule': {'briefSummary': 'Macular degeneration, also called age-related macular degeneration (AMD), is a leading cause of visual impairment and severe vision loss.\n\nAMD 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.\n\nRetinal 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.\n\nField of view will be monitored to reveal the possible slowing of disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Definite AMD diagnosis with documented disease progression within the past 6 months\n\n* Age: 50-85 years old\n* Ascertained differential diagnosis with the aid of diagnostic tools: fundus examination eye; analysis of the macular region using optical computed tomography (OCT)\n\nExclusion Criteria:\n\n* Psychiatric diseases\n* Type I and II diabetes\n* Patients with high refractive defects: myopia \\> 6 d; hyperopia \\> 4 d; astigmatism \\> 4 d\n* Corneal pathologies\n* Hereditary retinal diseases\n* Autoimmune diseases (uveitis)\n* Glaucoma\n* Oncological diseases\n* Liver and kidney disease\n* Inclusion in other clinical trials\n* Inability to understand informed consent and the purpose of the study\n* Women who are pregnant or who may become pregnant during treatment'}, 'identificationModule': {'nctId': 'NCT06351033', 'briefTitle': 'Ozonized Oil as Dietary Supplement in Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Neuromed IRCCS'}, 'officialTitle': 'Efficacy of Ozonated Oil as a Dietary Supplement in the Clinical Management of Patients With Macular Degeneration', 'orgStudyIdInfo': {'id': 'ADP_012023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Placebo', 'description': '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).'}, {'label': 'Ozonized Oil', 'description': '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.', 'interventionNames': ['Dietary Supplement: High ozonide (HOO) ozonated oil']}], 'interventions': [{'name': 'High ozonide (HOO) ozonated oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'ozonated oil with high ozonides (HOO) administered orally (os) in gastro-resistant capsules', 'armGroupLabels': ['Ozonized Oil']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pozzilli', 'country': 'Italy', 'facility': 'IRCCS Neuromed', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}], 'overallOfficials': [{'name': 'Eliana Palermo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Neuromed'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alba Di Pardo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Alba Di Pardo', 'investigatorAffiliation': 'Neuromed IRCCS'}}}}