Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-29 @ 12:24 PM
Study NCT ID:
NCT00709657
Status:
TERMINATED
Last Update Posted:
2014-11-14
First Post:
2008-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C495058', 'term': 'pegaptanib'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2008-07-01', 'studyFirstSubmitQcDate': '2008-07-02', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve head blood flow', 'timeFrame': 'before, one week after and three weeks after intravitreal injection with an anti-VEGF drug'}], 'secondaryOutcomes': [{'measure': 'Choroidal blood flow', 'timeFrame': 'before, one week after and three weeks after intravitreal injection with an anti-VEGF drug'}, {'measure': 'Retrobulbar blood flow', 'timeFrame': 'before, one week after and three weeks after intravitreal injection with an anti-VEGF drug'}, {'measure': 'Intraocular pressure', 'timeFrame': 'before, one week after and three weeks after intravitreal injection with an anti-VEGF drug'}, {'measure': 'Systemic blood pressure', 'timeFrame': 'before, one week after and three weeks after intravitreal injection with an anti-VEGF drug'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Age-related macular degeneration', 'anti-VEGF'], 'conditions': ['Macular Degeneration', 'Regional Blood Flow', 'Vascular Endothelial Growth Factor']}, 'descriptionModule': {'briefSummary': 'Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).\n\nHowever, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40 subjects ≥ 50 years of age\n* Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye\n* Good central or eccentric fixation\n\nExclusion Criteria:\n\n* History or previous Anti-VEGF therapy\n* History or previous intravitreal injection with any drug\n* Intraocular pressure ≥ 25\n* Glaucoma\n* History or presence of thromboembolic events\n* Diabetes mellitus\n* Blood donation during the previous 3 weeks\n* Ametropy ≥ 6 dpt'}, 'identificationModule': {'nctId': 'NCT00709657', 'briefTitle': 'The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion', 'orgStudyIdInfo': {'id': 'OPHT-060707'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.', 'interventionNames': ['Drug: ranibizumab, bevacizumab or pegaptanib']}], 'interventions': [{'name': 'ranibizumab, bevacizumab or pegaptanib', 'type': 'DRUG', 'description': 'measurements are performed one week before and after anti-VEGF intravitreal injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Clinical Pharmacology, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gerhard Garhöfer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Depatement of Clinical Pharmacology, Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Priv. - Doz. Dr', 'investigatorFullName': 'Gerhard Garhofer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}