Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT02131350
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2014-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008028', 'term': 'Light Coagulation'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006488', 'term': 'Hemostasis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2014-05-02', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'best corrected visual acuity', 'timeFrame': 'every month, up to 36 months', 'description': 'Best corrected visual acuity is measured with Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and analysed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Macula Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the mean gain in best corrected visual acuity and the number of intravitreal ranibizumab (IVR) injections under the combination treatment of IVR, focal/grid laser and panretinal photocoagulation. Our hypothesis is that suitable photocoagulation decreases the number of IVR injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable medication for the management of diabetes within 3 months\n* visual impairment due to focal or diffuse diabetic macula edema\n* decreased vision due to diabetic macula edema and not other causes\n\nExclusion Criteria:\n\n* concomitant conditions in the study eye that could prevent the improvement in VA on the study\n* active intraocular inflammation or infection in either eye\n* uncontrolled glaucoma in either eye\n* treatment with antiangiogenic drugs in the study eye within 3 months\n* history of stroke and uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT02131350', 'briefTitle': 'Combination Treatment of Intravitreal Ranibizumab, Focal/Grid Laser and Panretinal Photocoagulation in Patients With Diabetic Macula Edema', 'organization': {'class': 'OTHER', 'fullName': 'Shinshu University'}, 'orgStudyIdInfo': {'id': '2617'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab with Photocoagulation', 'interventionNames': ['Procedure: Photocoagulation', 'Drug: Ranibizumab']}], 'interventions': [{'name': 'Photocoagulation', 'type': 'PROCEDURE', 'description': 'Photocoagulation include focal/grid laser and/or panretinal photocoagulation', 'armGroupLabels': ['Ranibizumab with Photocoagulation']}, {'name': 'Ranibizumab', 'type': 'DRUG', 'armGroupLabels': ['Ranibizumab with Photocoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3908621', 'city': 'Matsumoto', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Department ou Ophthalmology Shinshu University School of Medicine', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shinshu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Ophthalmology Shinshu University School of Medicine', 'investigatorFullName': 'Takao Hirano', 'investigatorAffiliation': 'Shinshu University'}}}}