Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-17 @ 10:26 PM
Study NCT ID:
NCT03633266
Status:
UNKNOWN
Last Update Posted:
2018-08-17
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-10', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from baseline in best-corrected visual acuity (BCVA)', 'timeFrame': '3 years', 'description': 'Assessed using the ETDRS protocol'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in visual field', 'timeFrame': '3 years', 'description': 'Assessed on Humphery(30-2 and 60-4)'}, {'measure': 'chang from baseline in sructure of retina', 'timeFrame': '3 years', 'description': 'Assessed on Optical Coherence Tomography(OCT)'}, {'measure': 'chang from baseline in retinal neovascularization', 'timeFrame': '3 years', 'description': 'Assessed on Fundus Fluorescein Angiography(FFA)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anti-VEGF', 'Proliferative Diabetic Retinopathy', 'PRP', 'Vitrectomy']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of vitreoretinal surgery combined with anti-VEGF therapy in the replacement of intraoperative PRP in PDR therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ageā„18 years old;\n2. type 1 or type 2 diabetes.\n3. proliferative diabetic retinopathy with vitreous hemorrhage, and conservative treatment of vitreous hemorrhage without obvious absorption for 1 month requires vitreoretinal surgery;\n4. The postoperative refractive medium is clear and the pupil is large enough to obtain sufficient clear fundus\n\nExclusion Criteria:\n\n1. Previously received panretinal photocoagulation or unfinished panretinal photocoagulation;\n2. Pulling retinal detachment involving the macula or the presence of extensive fiber proliferation requires silicone oil filling;\n3. anterior chamber neovascularization or neovascular glaucoma;\n4. other vascular diseases such as retinal vein occlusion, arterial occlusion, etc;\n5. received intraocular anti-VEGF therapy or triamcinolone acetonide treatment which are still in the treatment period.'}, 'identificationModule': {'nctId': 'NCT03633266', 'briefTitle': 'Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Feasibility Study of Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy', 'orgStudyIdInfo': {'id': '10007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-VEGF', 'description': 'experimental group: vitreoretinal surgery combined with intraoperative anti-VEGF', 'interventionNames': ['Procedure: anti-VEGF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRP', 'description': 'Control group: vitreoretinal surgery combined with intraoperative PRP', 'interventionNames': ['Procedure: PRP']}], 'interventions': [{'name': 'anti-VEGF', 'type': 'PROCEDURE', 'description': 'vitreoretinal surgery combined with intraoperative anti-VEGF', 'armGroupLabels': ['anti-VEGF']}, {'name': 'PRP', 'type': 'PROCEDURE', 'description': 'vitreoretinal surgery combined with intraoperative PRP', 'armGroupLabels': ['PRP']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yong Wei, M.D', 'role': 'CONTACT', 'email': 'weiyongdoctor@163.com', 'phone': '+86 15057551266'}, {'name': 'Wei lin, M.D', 'role': 'CONTACT', 'email': 'linweiysg@163.com', 'phone': '+86 13587560390'}], 'overallOfficials': [{'name': 'Yong Wei, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Eye Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xiangtian Zhou', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}