Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-03 @ 8:30 AM
Study NCT ID:
NCT04464694
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-07-05', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative vitreous haemorrhage', 'timeFrame': 'From day 1 to week 4 after the vitrectomy', 'description': 'To compare the incidence of the early postoperative vitreous haemorrhage between two arms'}], 'secondaryOutcomes': [{'measure': 'Mean Best-corrected visual acuity (BCVA) at Month 3', 'timeFrame': 'Month 3 after vitrectomy', 'description': 'To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.'}, {'measure': 'Mean Best-corrected visual acuity (BCVA) at Month 6', 'timeFrame': 'Month 6 after vitrectomy', 'description': 'To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PDR', 'DME', 'ranibizumab', 'vitrectomy'], 'conditions': ['Proliferative Diabetic Retinopathy', 'Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '19584650', 'type': 'RESULT', 'citation': 'Lo WR, Kim SJ, Aaberg TM Sr, Bergstrom C, Srivastava SK, Yan J, Martin DF, Hubbard GB 3rd. Visual outcomes and incidence of recurrent vitreous hemorrhage after vitrectomy in diabetic eyes pretreated with bevacizumab (avastin). Retina. 2009 Jul-Aug;29(7):926-31. doi: 10.1097/IAE.0b013e3181a8eb88.'}, {'pmid': '21278146', 'type': 'RESULT', 'citation': 'Zhao LQ, Zhu H, Zhao PQ, Hu YQ. A systematic review and meta-analysis of clinical outcomes of vitrectomy with or without intravitreal bevacizumab pretreatment for severe diabetic retinopathy. Br J Ophthalmol. 2011 Sep;95(9):1216-22. doi: 10.1136/bjo.2010.189514. Epub 2011 Jan 27.'}, {'pmid': '28498374', 'type': 'RESULT', 'citation': 'Comyn O, Wickham L, Charteris DG, Sullivan PM, Ezra E, Gregor Z, Aylward GW, da Cruz L, Fabinyi D, Peto T, Restori M, Xing W, Bunce C, Hykin PG, Bainbridge JW. Ranibizumab pretreatment in diabetic vitrectomy: a pilot randomised controlled trial (the RaDiVit study). Eye (Lond). 2017 Sep;31(9):1253-1258. doi: 10.1038/eye.2017.75. Epub 2017 May 12.'}]}, 'descriptionModule': {'briefSummary': "To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.", 'detailedDescription': "Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.\n\nSecondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.\n\nStudy design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ageā„18 years old;\n2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema\n3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion\n4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation;\n2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months\n3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;\n4. Clinically confirmed intraocular pressure (IOP) \\>=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye"}, 'identificationModule': {'nctId': 'NCT04464694', 'briefTitle': 'Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema', 'orgStudyIdInfo': {'id': 'XH-20-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab', 'description': 'Single intravitreal injection of ranibizumab (0.5 mg) 3\\~7 days before vitrectomy', 'interventionNames': ['Drug: Ranibizumab', 'Procedure: Pars plana vitrectomy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham injection', 'description': 'Sham injection 3\\~7 days before vitrectomy', 'interventionNames': ['Other: Sham injection', 'Procedure: Pars plana vitrectomy']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3\\~7 days before vitrectomy.', 'armGroupLabels': ['Ranibizumab']}, {'name': 'Sham injection', 'type': 'OTHER', 'description': 'Patients will receive single sham injection 3\\~7 days before vitrectomy.', 'armGroupLabels': ['Sham injection']}, {'name': 'Pars plana vitrectomy', 'type': 'PROCEDURE', 'otherNames': ['Vitrectomy'], 'description': 'Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina', 'armGroupLabels': ['Ranibizumab', 'Sham injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315012', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Quanyong Yi', 'role': 'CONTACT', 'email': '1067572232@qq.com', 'phone': '13586543802'}], 'facility': 'Ningbo Eye Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '2000831', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Xin Huang', 'role': 'CONTACT', 'email': 'xinhuang66@icloud.com', 'phone': '13818902665'}], 'facility': 'Eye & Ent Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '2000892', 'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Peiquan Zhao', 'role': 'CONTACT', 'email': 'zhaopeiquan@126.com', 'phone': '+8613311620396'}], 'facility': 'Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Peiquan Zhao', 'role': 'CONTACT', 'email': 'Zhaopeiquan@126.com', 'phone': '13311620396'}], 'overallOfficials': [{'name': 'Peiquan Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}