Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT04377295
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2020-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-03', 'studyFirstSubmitDate': '2020-05-03', 'studyFirstSubmitQcDate': '2020-05-03', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab', 'timeFrame': 'one year', 'description': 'The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography (OCT).\n\nThe parameter analyzed by OCT was: Central Macular Thickness (micron).'}, {'measure': 'Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab', 'timeFrame': 'one year', 'description': 'The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography angiography (OCTA).\n\nThe parameter analyzed by OCTA was: retinal vessel density (%)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation Maculopathy']}, 'descriptionModule': {'briefSummary': 'This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.', 'detailedDescription': 'The radiation maculopathy is a consequence of radiotherapy for treatment of choroidal melanoma. The radiation maculopathy is characterized by the compromission of the macular microvasculature that can lead to the leakage, lipid exudates, hemorrhages, teleangiectasie, macular edema, non perfusion areas with consequent significant impaiment of visual acuity.\n\nRanibizumab is a vascular endothelial growth factor antagonist and it represents an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after intravitreal injections of Ranibizumab at the last follow up to one year in patients affected by radiation maculopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age older than 40 years\n* diagnosis of radiation maculopathy\n* treatment-naïve with Ranibizumab\n* absence of other vitreoretinal and vascular retinal diseases\n\nExclusion Criteria:\n\n* age younger than 40 years\n* No diagnosis of radiation maculopathy\n* previous treatments with Ranibizumab\n* presence of vitreoretinal and vascular retinal diseases'}, 'identificationModule': {'nctId': 'NCT04377295', 'briefTitle': 'Evaluation of Retinal and Vascular Features in Radiation Maculopathy After Intravitreal Injections of Ranibizumab', '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 Ranibizumab in Radiation Maculopathy', 'orgStudyIdInfo': {'id': 'PT1034/20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ranibizumab 0.5Mg/0.05Ml Oph Inj', 'type': 'DRUG', 'description': 'All patients received one monthly intravitreal injection of Ranibizumab (0.5 mg/0.05 ml) through the pars plana under aseptic conditions until maximum visual acuity was achieved and there was no sign of macular edema at optical coherence tomography'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gilda Cennamo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gilda Cennamo', 'investigatorAffiliation': 'Federico II University'}}}}