Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT05969418
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2023-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2023-07-23', 'studyFirstSubmitQcDate': '2023-07-23', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc', 'timeFrame': 'more than sixmonths'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Macular Degeneration Choroidal Neovascularization']}, 'descriptionModule': {'briefSummary': 'To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.', 'detailedDescription': 'Exudative neovascular macular degeneration is the primarily an age-related retinal condition The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features in order to choose the best therapy .\n\nThe study evaluates the changes in structural optical coherence tomography and optical coherence tomography angiography features in neovascular macular degeration patients undergoing ANTI-VEGF treatments using artificial intelligence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: age older than 50 years\n\n* diagnosis of neovascular macular degeneration\n* absence of previous retinal surgery and congenital eye diseases.\n* absence of errors of refraction\n* absence of lens opacities\n* absence of low-quality OCT and OCTA images\n\nExclusion Criteria:• age younger than 50 years\n\n* previous retinal surgery and congenital eye diseases\n* errors of refraction\n* lens opacities\n* low-quality OCT and OCTA images'}, 'identificationModule': {'nctId': 'NCT05969418', 'acronym': 'OCTA', 'briefTitle': 'Deep Learning Optical Coherence Tomography (OCT) and OCT Angiography (OCTA) in NVC', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': '05809850'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with neovascular macular degeneration', 'interventionNames': ['Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter']}, {'label': 'healty patients matched age and sex without any ocular disease', 'interventionNames': ['Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter']}], 'interventions': [{'name': 'Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment', 'armGroupLabels': ['Patients with neovascular macular degeneration', 'healty patients matched age and sex without any ocular disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80121', 'city': 'Naples', 'country': 'Italy', 'facility': 'Federico II University', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Ciro Costagliola, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}