Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01219205
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2010-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Major and Macular Branched Retinal Venous Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-12', 'studyFirstSubmitDate': '2010-10-10', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of intravitreal bevacizumab', 'timeFrame': 'baseline and 12 months after initial injection', 'description': 'the number on intravitreal bevacizumab during follow-up'}], 'secondaryOutcomes': [{'measure': 'cytokine levels in aqueous humor', 'timeFrame': 'before intravitreal injection', 'description': 'cytokine levels in aqueous humor before bevacizumab injection'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['macular edema secondary to retinal benous occlusion'], 'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'Although it is important in the clinical management to classify BRVO into subtypes based on the location of the occlusion (major or macular), few studies have provided such information\\[8,9\\]. The aim of this study was to evaluate the outcome of patients with macular edema due to Branch retinal vein occlusion who were treated with intravitreal bevacizumab injection and to determine the concentrations of cytokines in the aqueous humor according to the site of the occlusion.', 'detailedDescription': 'Branch retinal vein occlusion is the second most frequent major retinal vascular disease after diabetic retinopathy. One of the main reasons for visual loss in BRVO is the development of macular edema. Treatment options for BRVO include grid laser treatment, intravitreal injection of steroids, surgical procedures, and off-label treatment with intravitreal anti-vascular endothelial growth factor (VEGF) agents. During recent years, intravitreal anti-VEGF treatment with bevacizumab has been shown to efficiently reduce macular edema and improve visual acuity in numerous case series and prospective or retrospective studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* macular edema involving the center of the fovea with a minimum central macular thickness at baseline of ≥250 μm\n\nExclusion Criteria:\n\n* previous vitreoretinal surgery, intravitreal injections or laser treatment'}, 'identificationModule': {'nctId': 'NCT01219205', 'briefTitle': 'Major and Macular Branched Retinal Venous Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'Intravitreal Bevacizumab for Macular Edema Secondary to Major and Macular Branch Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': '2009_128'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'major branched retinal venous occlusion', 'interventionNames': ['Procedure: intravitreal bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'macular branched retinal venous occlusion', 'interventionNames': ['Procedure: intravitreal bevacizumab']}], 'interventions': [{'name': 'intravitreal bevacizumab', 'type': 'PROCEDURE', 'description': 'Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ㎖) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.', 'armGroupLabels': ['macular branched retinal venous occlusion', 'major branched retinal venous occlusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-704', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Ji Won Lim', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'overallOfficials': [{'name': 'Ji Won Lim, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Hallym Medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ji Won Lim', 'oldOrganization': 'Hallym Medical center'}}}}