Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-03-01 @ 9:53 PM
Study NCT ID:
NCT00740168
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2008-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab Treatment and Retinal Vessel Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2008-08-20', 'studyFirstSubmitQcDate': '2008-08-20', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter of retinal vessels and dynamic vessel reaction', 'timeFrame': 'Measurements before and after administration'}], 'secondaryOutcomes': [{'measure': 'Baroreflex sensitivity, heart frequence variability, reaction to handgrip test', 'timeFrame': 'Measurements before and after administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bevacizumab', 'cancer'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '23668549', 'type': 'DERIVED', 'citation': 'Reimann M, Folprecht G, Haase R, Trautmann K, Ehninger G, Reichmann H, Ziemssen F, Ziemssen T. Anti-Vascular endothelial growth factor therapy impairs endothelial function of retinal microcirculation in colon cancer patients - an observational study. Exp Transl Stroke Med. 2013 May 13;5(1):7. doi: 10.1186/2040-7378-5-7.'}]}, 'descriptionModule': {'briefSummary': 'Bevacizumab might influence the dynamic vessel function after being administered intravenously.', 'detailedDescription': 'By monitoring different vessel and circulation parameters (e.g. dynamic retinal vessel analyzer) the study will clarify the potential hemodynamic effects of bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer patients with first bevacizumab treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who wish and need bevacizumab treatment for underlying disease\n\nExclusion Criteria:\n\n* previous bevacizumab treatment\n* known eye disease, eye surgery or eye trauma in history\n* myopia \\>-2.0 dpt\n* hyperopia \\> +2.0 dpt.\n* relevant media opacity of the lens\n* acute heart disease, ischemic insult, proven coronary heart disease\n* cardiac arrhythmia or vessel anomalies\n* seizure disorder or episode in history\n* migraine\n* treatment with corticosteroids within 4 weeks before study inclusion\n* intake of vasoactive drugs like AT-1 or glitazone\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00740168', 'acronym': 'BevaRet', 'briefTitle': 'Bevacizumab Treatment and Retinal Vessel Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Analysis of Retinal Vessel Reaction and Monitoring of Circulation Parameters During Bevacizumab Therapy', 'orgStudyIdInfo': {'id': 'B-ANF1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TG', 'description': 'Bevacizumab treatment group with metastasized cancer', 'interventionNames': ['Drug: bevacizumab treatment']}], 'interventions': [{'name': 'bevacizumab treatment', 'type': 'DRUG', 'otherNames': ['Avastin', 'ATC code: L01XC07', 'CAS Registry Number:216974-75-3', 'VEGF-inhibitor'], 'description': 'single infusion 10 mg/kg', 'armGroupLabels': ['TG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Autonomic lab (ANF)', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Tjalf Ziemssen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurological University Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}