Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-09 @ 11:50 AM
Study NCT ID:
NCT02645734
Status:
UNKNOWN
Last Update Posted:
2016-01-05
First Post:
2016-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'C533178', 'term': 'aflibercept'}], '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 133}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2016-01-02', 'studyFirstSubmitQcDate': '2016-01-04', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'until 6 month'}], 'secondaryOutcomes': [{'measure': 'central subfield thickness(CCT)', 'timeFrame': 'until 6 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .\n\nThe study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)\n* Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent\n* Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months\n\nExclusion Criteria:\n\n* Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye\n* Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months\n* Substantial cataract, history of uveitis\n* Macular edema due to a cause other than DME\n* VMT(Vitreomacular traction ) and ERM (epiretinal membrane)'}, 'identificationModule': {'nctId': 'NCT02645734', 'briefTitle': 'The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '93210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Injection intravitreous bevacizumab', 'description': 'Injection intravitreous bevacizumab at a dose 1.25mg', 'interventionNames': ['Drug: bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Injection ziv-aflibercept at dose of 1.25 mg', 'description': 'Injection ziv-aflibercept at dose of 1.25 mg', 'interventionNames': ['Drug: ziv-aflibercept 1.25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Injection ziv-aflibercept at dose of 2.5 mg', 'description': 'Injection ziv-aflibercept at dose of 2.5 mg', 'interventionNames': ['Drug: ziv-aflibercept 2.5mg']}], 'interventions': [{'name': 'bevacizumab', 'type': 'DRUG', 'description': '1.25 mg of bevacizumab is injected', 'armGroupLabels': ['Injection intravitreous bevacizumab']}, {'name': 'ziv-aflibercept 1.25 mg', 'type': 'DRUG', 'description': '1.25 mg of ziv-aflibercept is injected', 'armGroupLabels': ['Injection ziv-aflibercept at dose of 1.25 mg']}, {'name': 'ziv-aflibercept 2.5mg', 'type': 'DRUG', 'description': '2.5 mg of ziv-aflibercept is injected', 'armGroupLabels': ['Injection ziv-aflibercept at dose of 2.5 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Masoud Soheilian, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}], 'facility': 'Islamic Republic of Iran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Masoud Soheilian, MD', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '009822591616'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Zahra Rabbani Khah', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}