Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-21 @ 3:21 AM
Study NCT ID:
NCT01854593
Status:
COMPLETED
Last Update Posted:
2014-07-14
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014823', 'term': 'Vitreous Hemorrhage'}], 'ancestors': [{'id': 'D005130', 'term': 'Eye Hemorrhage'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D014821', 'term': 'Vitrectomy'}], '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'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ayumu.m76@gmail.com', 'phone': '+81-3-3293-1711', 'title': 'Dr. Ayumu Manabe', 'phoneExt': '429', 'organization': 'Department of Ophthalmology, Surugadai Hospital of Nihon University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': '1 month after vitrectomy.', 'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Intra Operative Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End of the surgery.', 'description': 'Calculate the number of coagulators for the intra operative hemorrhage.', 'unitOfMeasure': 'coagulators', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Vitreous Hemorrhage.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Reoperation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'Vitreoretinal reoperation due to recurrent vitreous hemorrhage.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vascular Endothelial Growth Factor Concentration in Vitreous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '1315', 'spread': '1153', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Start of surgery.', 'description': 'Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.', 'unitOfMeasure': 'μg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Endolaser Photocoagulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1260', 'spread': '686', 'groupId': 'OG000'}, {'value': '1335', 'spread': '663', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.667', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End of surgery.', 'description': 'Number of intraoperative endolaser photocoagulation.', 'unitOfMeasure': 'photocoagulation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Iatrogenic Retinal Tears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.593', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of surgery.', 'description': 'The number of participants who had intraoperative iatrogenic retinal tears.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '20', 'groupId': 'OG000'}, {'value': '56', 'spread': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.298', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'End of surgery.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Best Corrected Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.929', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 mouth after surgery.', 'description': 'Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.\n\nThe minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.445', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month', 'description': 'Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.\n\nThe higher values represent a worse outcome.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Neovascular Glaucoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab Injection and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.131', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after the surgery.', 'description': 'The number of participants with progressive or persistent neovascular glaucoma after surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Elevated Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab Injection and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.149', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 month after the surgery.', 'description': 'The number of participants with elevated intraocular pressure after surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gas Tamponade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab Injection and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.670', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of surgery.', 'description': 'The number of participants with gas tamponade at the end of the surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Silicon Oil Tamponade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab Injection and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'OG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nVitrectomy: vitrectomy of 25 gauge system.\n\nSham injection: Sham injection one day before vitrectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.378', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of surgery.', 'description': 'The number of participants with silicon oil tamponade at the end of the surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\nBevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)\n\nVitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'FG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\nSham injection: Sham injection one day before vitrectomy\n\nVitrectomy: vitrectomy of 25 gauge system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab and Vitrectomy', 'description': '0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.\n\n* Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)\n* Vitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'BG001', 'title': 'Sham Injection and Vitrectomy', 'description': 'Sham injection one day before operation and vitrectomy.\n\n* Sham injection: Sham injection one day before vitrectomy\n* Vitrectomy: vitrectomy of 25 gauge system.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '12.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preoperative best corrected visual acuity', 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '1.14', 'spread': '0.58', 'groupId': 'BG001'}, {'value': '1.11', 'spread': '0.59', 'groupId': 'BG002'}]}]}], 'paramType': 'LOG_MEAN', 'description': 'Preoperative best corrected visual acuity', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intra Ocular Pressure', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '2.69', 'groupId': 'BG000'}, {'value': '14.6', 'spread': '3.42', 'groupId': 'BG001'}, {'value': '15.0', 'spread': '3.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hyperlipidemia', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '7.6', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Use of anticoagulants', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lens status', 'classes': [{'title': 'phakic', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'pseudophakic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Persistent vitreous hemorrhage', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous panretinal photocoagulation', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Incomplete', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'preoperative Iris neovascularization or neovascular glaucoma', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-11', 'studyFirstSubmitDate': '2013-05-13', 'resultsFirstSubmitDate': '2013-12-29', 'studyFirstSubmitQcDate': '2013-05-13', 'lastUpdatePostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-11', 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': '1 month', 'description': 'Vitreoretinal reoperation due to recurrent vitreous hemorrhage.'}], 'secondaryOutcomes': [{'measure': 'Intra Operative Hemorrhage', 'timeFrame': 'End of the surgery.', 'description': 'Calculate the number of coagulators for the intra operative hemorrhage.'}, {'measure': 'Postoperative Vitreous Hemorrhage.', 'timeFrame': '1 month', 'description': 'Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.'}, {'measure': 'Vascular Endothelial Growth Factor Concentration in Vitreous', 'timeFrame': 'Start of surgery.', 'description': 'Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.'}, {'measure': 'Endolaser Photocoagulation', 'timeFrame': 'End of surgery.', 'description': 'Number of intraoperative endolaser photocoagulation.'}, {'measure': 'Iatrogenic Retinal Tears', 'timeFrame': 'End of surgery.', 'description': 'The number of participants who had intraoperative iatrogenic retinal tears.'}, {'measure': 'Surgical Time', 'timeFrame': 'End of surgery.'}, {'measure': 'Postoperative Best Corrected Visual Acuity', 'timeFrame': '1 mouth after surgery.', 'description': 'Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.\n\nThe minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome.'}, {'measure': 'Best Corrected Visual Acuity Change', 'timeFrame': '1 month', 'description': 'Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.\n\nThe higher values represent a worse outcome.'}, {'measure': 'Postoperative Neovascular Glaucoma', 'timeFrame': 'Within 1 month after the surgery.', 'description': 'The number of participants with progressive or persistent neovascular glaucoma after surgery.'}, {'measure': 'Elevated Intraocular Pressure', 'timeFrame': 'Within 1 month after the surgery.', 'description': 'The number of participants with elevated intraocular pressure after surgery.'}, {'measure': 'Gas Tamponade', 'timeFrame': 'End of surgery.', 'description': 'The number of participants with gas tamponade at the end of the surgery.'}, {'measure': 'Silicon Oil Tamponade', 'timeFrame': 'End of surgery.', 'description': 'The number of participants with silicon oil tamponade at the end of the surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Proliferative Diabetic Retinopathy', 'Diabetic Traction Retinal Detachment', 'Vitreous Hemorrhage']}, 'descriptionModule': {'briefSummary': 'We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.', 'detailedDescription': 'Early postoperative hemorrhage in proliferative diabetic retinopathy (PDR) patients is a major complication. Intravitreal injection of anti-vascular endothelial growth factor (VEGF) has reported to reduce vitreous hemorrhage. Recently, numerous reports have shown the efficacy of reducing neovascularization activity before vitrectomy by preoperative intravitreal injection of anti-VEGF agents. When intravitreal bevacizumab (IVB) injection is used as an adjunct therapy, a shortterm effect is needed. Because it is reported some adverse events caused by bevacizumab injection. Hattori et al reported intravitreal injection of 0.16 mg/0.05 ml bevacizumab in PDR patients marked blockage of intravitreal VEGF concentrations in the pilot study. The purpose of this study is to evaluate low dose of intravitreal bevacizumab as a preoperative adjunct therapy reduce the postoperative vitreous hemorrhage. This study involves PDR patients who underwent vitrectomy between May 2012 and August 2013 at Surugadai Hospital of Nihon University. The risks to participants are accompanied by the intravitreal injection of bevacizumab (especially the possibility of endophthalmitis and thromboembolic events).\n\nBetween June 2012 and August 2013, one investigator (AM) randomized PDR patients with an indication for primary 25-gauge vitrectomy into a sham group and an IVB group. One day after injection, three surgeons except AM conducted the surgeries. Vitreous samples were collected at the start of surgery, and intraoperative and postoperative complications were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)\n* Indicated for vitrectomy\n\nExclusion Criteria:\n\n* History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months'}, 'identificationModule': {'nctId': 'NCT01854593', 'briefTitle': 'Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Nihon University'}, 'officialTitle': 'Prospective Randomized Controlled Study of Intravitreal Injection of 0.16 mg Bevacizumab One Day Before Surgery for Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'CCT-NAPN-23170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab injection and vitrectomy', 'description': '0.16 mg/0.05 ml bevacizumab intravitreal injection one day before vitrectomy.', 'interventionNames': ['Drug: Bevacizumab', 'Procedure: Vitrectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham injection and vitrectomy', 'description': 'Sham injection one day before vitrectomy.', 'interventionNames': ['Procedure: Vitrectomy', 'Device: Sham injection']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': '0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)', 'armGroupLabels': ['Bevacizumab injection and vitrectomy']}, {'name': 'Vitrectomy', 'type': 'PROCEDURE', 'description': 'vitrectomy of 25 gauge system.', 'armGroupLabels': ['Bevacizumab injection and vitrectomy', 'Sham injection and vitrectomy']}, {'name': 'Sham injection', 'type': 'DEVICE', 'description': 'Sham injection one day before vitrectomy', 'armGroupLabels': ['Sham injection and vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '101-8309', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Surugadai Nihon University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Ayumu Manabe', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ayumu Manabe', 'investigatorFullName': 'Ayumu Manabe', 'investigatorAffiliation': 'Nihon University'}}}}