Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-29 @ 7:22 AM
Study NCT ID:
NCT04499157
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2020-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2020-07-29', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment', 'timeFrame': 'from day 0 to 2 years', 'description': 'Variation of visual field of open angle-glaucoma patients with MEMOPTIC treatment versus visual field of open angle-glaucoma patients without MEMOPTIC treatment. Visual field is measure with METROVISION Visual Field 24-2, a full field projection perimeter entirely compatible with the Goldmann standard and modern perimetry standard. It allows high resolution static perimetry as well as kinetic perimetry with automated and manual modes. Automated static perimetry is one of the methods used to screen and follow up patients who have glaucoma. It consists of approximately 100 quantitative threshold measures that permit evaluation of retinal sensitivity. Each measure is standardized in a population free of ocular disease, and two simple statistics are calculated: mean deviation (MD) and pattern standard deviation (PSD). These indices are widely used in glaucoma clinical trials and patient follow-up.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Citicoline', 'Gingko biloba', 'magnesium', 'Open-angle Glaucoma', 'visual field', 'MEMOPTIC'], 'conditions': ['Open-angle Glaucoma', 'Visual Field']}, 'descriptionModule': {'briefSummary': "Open-angle glaucoma is a degeneration of the optic nerve, highlighted by campimetric alterations, and wose only current therapeutic target is the lowering of the intra-ocular pressure (using eye drops, surgery or laser). MEMOPTIC is a tablet combining citicoline, magnesium and Gingko biloba, which have a neuroprotective effect already used in neurodegenerative diseases such as Alzheimer's disease for example. Citicoline has also shown several promising results in ophthalmological diseases (glaucoma, amblyopia or more recently in ischemic optic neuropathies). The citicoline used in eye drops (NEURODROP) has already shown results on the preservation of the vision of glaucomatous patients.\n\nThe purpose of this project is to determine if MEMOPTIC can have an effect, in addition to the conventional treatments, in the preservation of vision of patients treated for an open-angle glaucoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of GCAO defined by OCT RNFL alterations and visual fields defects\n* age between 20 and 80 years old\n* Well controled intra-ocular pressure under treatment (PIO\\<21mmHg or decreased by 20% compared to initial the PIO)\n\nExclusion Criteria:\n\n* retinal or macular disease\n* diagnosis of cataract or surgery of cataract during the follow-up\n* allergy to citicolin\n* ocular hypertonia due to a secondary cause (like corticosteroids)\n* history of anterior, intermediate or posterior uveitis\n* general treatment affecting PIO (beta blockers, corticosteroids)\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04499157', 'acronym': 'MEMO-GCAO', 'briefTitle': 'Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Effect of MEMOPTIC on Visual Field of Patients Followed for a Chronic Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'PI2019_843_0061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEMOPTIC added to the usual treatment of glaucoma', 'description': 'MEMOPTIC added to the usual treatment of glaucoma', 'interventionNames': ['Drug: MEMOPTIC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual treatment of glaucoma', 'description': 'usual treatment of glaucoma', 'interventionNames': ['Drug: usual treatment of glaucoma']}], 'interventions': [{'name': 'MEMOPTIC', 'type': 'DRUG', 'description': 'Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following', 'armGroupLabels': ['MEMOPTIC added to the usual treatment of glaucoma']}, {'name': 'usual treatment of glaucoma', 'type': 'DRUG', 'description': 'Patients will receive only their usual treatment of glaucoma.', 'armGroupLabels': ['usual treatment of glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Claire Iscar, MD', 'role': 'CONTACT', 'email': 'Iscar.claire@chu-amiens.fr', 'phone': '(33)322089200'}], 'overallOfficials': [{'name': 'Claire Iscar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}