Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-15 @ 3:02 AM
Study NCT ID:
NCT04138420
Status:
COMPLETED
Last Update Posted:
2019-10-24
First Post:
2019-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2019-10-19', 'studyFirstSubmitQcDate': '2019-10-22', 'lastUpdatePostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of retinal structural features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab', 'timeFrame': 'three months', 'description': 'The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography. The parameters analyzed by optical coherence tomography: Central Macular Thickness and Subfoveal Choroidal thickness (microns).'}, {'measure': 'Study of retinal vascular features in exudative age-related macular degeneration after intravitreal injections of Bevacizumab', 'timeFrame': 'three months', 'description': 'The effectiveness of Bevacizumab injections for treating exudative age-related macular degeneration using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density (%).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optical coherence tomography angiography', 'optical coherence tomography angiography angiography', 'bevacizumab', 'vascular endothelial growth factor antagonists', 'intravitreal injection'], 'conditions': ['Exudative Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study evaluates the retinal and vascular features in patients with macular degeneration under the effects of Bevacizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.', 'detailedDescription': 'Bevacizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment for exudative age-related macular degeneration acting on vascular hyperpermeability.\n\nThe optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed and quantitative analysis of retinal and vascular features.\n\nThe study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Bevacizumab in exudative AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 50 years with diagnosis of exudative age-relative macular degeneration. They did not present other ophthalmological disease and did not receive previous treatment before Bevacizumab.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 50 years, diagnosis of exudative age-related macular degeneration, treatment-naïve with Bevacizumab for exudative age-related macular degeneration.\n\nExclusion Criteria:\n\n* age younger than 50 years, diagnosis of exudative macular degeneration due to other causes, previous treatments before Bevacizumab for exudative age-related macular degeneration.'}, 'identificationModule': {'nctId': 'NCT04138420', 'briefTitle': 'Evaluation of Retinal and Vascular Features in Macular Degeneration After Intravitreal Injections of Bevacizumab', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Study of Retinal and Vascular Features by Optical Coherence Tomography and Optical Coherence Tomography Angiography After Intravitreal Injections of Bevacizumab in Exudative Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'PT1124/14'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving Bevacizumab', 'description': 'Bevacizumab, intravitreal injection, three monthly, dosage: 1.25 mg/0.05 mL.', 'interventionNames': ['Drug: Bevacizumab Injection']}], 'interventions': [{'name': 'Bevacizumab Injection', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)', 'armGroupLabels': ['Patients receiving Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80100', 'city': 'Naples', 'country': 'Italy', 'facility': 'University of Naples "Federico II"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Gilda Cennamo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gilda Cennamo', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}