Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-27 @ 4:04 PM
Study NCT ID:
NCT01027468
Status:
COMPLETED
Last Update Posted:
2019-04-24
First Post:
2009-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D056965', 'term': 'Injections, Intraocular'}], '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'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stefan.sacu@meduniwien.ac.at', 'phone': '+43404001', 'title': 'Assoc.Prof.PD.Dr.Stefan Sacu', 'phoneExt': '7937', 'organization': 'Medical University of Vienna'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': '3 year follow-up of intravitreal application of bevacizumab', 'otherNumAtRisk': 160, 'otherNumAffected': 0, 'seriousNumAtRisk': 160, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'intraocular inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vision', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '3 year follow-up of intravitreal application of bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years after first intravitreal bevacizumab treatment', 'description': 'Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CRT (Central Retinal Thickness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '3 year follow-up of intravitreal application of bevacizumab'}], 'classes': [{'categories': [{'measurements': [{'value': '319', 'spread': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years after initial intravitreal bevacizumab treatment', 'description': 'Central retinal thickness measured in µm', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Systemic Complications After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '3 year follow-up of intravitreal application of bevacizumab'}], 'classes': [{'title': 'Retinal Detachment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Endophthalmitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Severe intraocular inflammation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'thromboembolic disease with myocardial infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years after initial bevacizumab treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': '3 year follow-up of patients with intravitreal application of bevacizumab: From August 2005 to July 2006: 1 mg (0.04 mL) of bevacizumab After July 2006: 2.5 mg (0.1 mL) of Bevacizumab Follow-up intervals: 6-8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Medical University of Vienna, Department of Ophthalmology during September 2008-July 2009 with a mean of 3 year follow-up after initial Bevacizumab intravitreal treatment', 'preAssignmentDetails': 'Inclusion criteria:\n\n* patients treated with bevacizumab due to wet age-related macular degeneration\n* follow-up of 3 years\n\nExclusion criteria:\n\n\\- patients with other macular diseases'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': '3 year follow-up of intravitreal application of bevacizumab'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '77.24', 'spread': '10.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-03', 'studyFirstSubmitDate': '2009-12-07', 'resultsFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2009-12-07', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-07', 'studyFirstPostDateStruct': {'date': '2009-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vision', 'timeFrame': '3 years after first intravitreal bevacizumab treatment', 'description': 'Best-corrected visual acuity converted to logMAR (MAR=minimum angle of resolution) for statistical analysis'}, {'measure': 'CRT (Central Retinal Thickness)', 'timeFrame': '3 years after initial intravitreal bevacizumab treatment', 'description': 'Central retinal thickness measured in µm'}], 'secondaryOutcomes': [{'measure': 'Systemic Complications After Treatment', 'timeFrame': '3 years after initial bevacizumab treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bevacizumab, choroidal neovascularization'], 'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': '200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).', 'detailedDescription': 'In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any subtype of neovascular age-related macular degeneration\n* age of 50 years or older\n* initial treatment with intravitreal bevacizumab between August 2005 and June 2006\n\nExclusion Criteria:\n\n* previous vitrectomy\n* presence of cystoid macular edema without choroidal neovascularization\n* Uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT01027468', 'briefTitle': 'Long-term Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Functional, Morphological And Safety Results After Intravitreal Bevacizumab Treatment Of Neovascular Age-related Macular Degeneration - 3 Years Of Follow-up', 'orgStudyIdInfo': {'id': 'EK 548/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1', 'description': 'bevacizumab intravitreal injection', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['intraocular injection'], 'description': 'intraocular bevacizumab injection', 'armGroupLabels': ['group 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stefan Sacu, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Medical University of Vienna, Austria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'Stefan Sacu', 'investigatorAffiliation': 'Medical University of Vienna'}}}}