Ignite Creation Date:
2025-12-25 @ 4:39 AM
Ignite Modification Date:
2026-03-06 @ 7:59 AM
Study NCT ID:
NCT01422018
Status:
UNKNOWN
Last Update Posted:
2011-09-23
First Post:
2011-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-09-22', 'studyFirstSubmitDate': '2011-08-05', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in best-corrected visual acuity (BCVA)', 'timeFrame': 'from month 0 to month 6 in monthly schedule (upto 6 months)', 'description': 'ETDRS BCVA will be measured after 6 6 serial IVB.'}], 'secondaryOutcomes': [{'measure': 'amount of hard exudates detected on fundus photography', 'timeFrame': 'from month 0 to month 6 in bimonthly schedule (upto 6 months)', 'description': 'on fundus photography'}, {'measure': 'macular edema detected by optical coherent tomography', 'timeFrame': 'from month 0 to month 6 in bimonthly schedule (upto 6 months)', 'description': 'central subfield thickness will be measured.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['clinically significant macular edema', 'diabetic macular edema', 'focal edema', 'focal laser photocoagulation', 'hard exudates', 'intravitreal bevacizumab'], 'conditions': ['Diabetes Complications']}, 'descriptionModule': {'briefSummary': 'Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.\n\nDesign: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (\\< 500 µm from fovea).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients of either gender aged \\> 18 years\n2. patients with type 2 diabetes\n3. central macular thickness \\> 300 µm on OCT\n4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (\\< 500 µm)\n5. an area of retinal thickening less than 2 disc areas in diameter\n6. 67% or more of leakage associated with microaneurysms\n\nExclusion Criteria:\n\n1. eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye\n2. eyes with any pharmacologic intervention on fellow eye within 6 months\n3. history of ocular diseases other than diabetic retinopathy\n4. surgical history other than cataract extraction with intraocular lens implantation\n5. panretinal photocoagulation within 3 months of enrollment\n6. media opacity\n7. any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.'}, 'identificationModule': {'nctId': 'NCT01422018', 'briefTitle': 'Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'orgStudyIdInfo': {'id': 'KC11MISI0439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one arm for Anastin injection', 'description': 'intravitreal Avastin injection', 'interventionNames': ['Drug: Avastin (bevacizumab)']}], 'interventions': [{'name': 'Avastin (bevacizumab)', 'type': 'DRUG', 'description': 'Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)', 'armGroupLabels': ['one arm for Anastin injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-070', 'city': 'Seocho', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sohee Jeon, MD', 'role': 'CONTACT', 'email': 'soheeeee@gmail.com', 'phone': '82-10-7176-1357'}], 'facility': "Seoul St Mary's hospital", 'geoPoint': {'lat': 37.49056, 'lon': 127.02}}], 'centralContacts': [{'name': 'Sohee Jeon, MD', 'role': 'CONTACT', 'email': 'soheeeee@gmail.com', 'phone': '82-10-7176-1357'}, {'name': 'Won ki Lee, DM, Ph.D', 'role': 'CONTACT', 'email': 'wklee@catholic.ac.kr', 'phone': '82-2-2258-1188'}], 'overallOfficials': [{'name': 'Won ki Lee, MD Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pf.', 'investigatorFullName': 'Won Ki Lee', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}