Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-31 @ 4:39 PM
Study NCT ID:
NCT05642793
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C527363', 'term': 'KH902 fusion protein'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-11-30', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of postvitrectomy complication', 'timeFrame': '6 months', 'description': 'postvitrectomy DME, VH (recurrent or nonabsorbent), NVG'}], 'secondaryOutcomes': [{'measure': 'postvitrectomy BCVA', 'timeFrame': '6 months', 'description': 'BCVA at 1,3,6 month after vitrectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitrectomy'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PDR patients undergoing vitrectomy\n\nExclusion Criteria:\n\n* patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy\n* patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy\n* patients who had received complete PRP before vitrectomy\n* patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT05642793', 'briefTitle': 'Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients', 'orgStudyIdInfo': {'id': 'PDR vitrectomy1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group 1 (proactive use of conbercept after vitrectomy)', 'description': 'proactive use of conbercept after vitrectomy', 'interventionNames': ['Drug: proactive Anti-VEGF (conbercept) use']}, {'type': 'EXPERIMENTAL', 'label': 'group 2 (passive use of conbercept after vitrectomy)', 'description': 'passive use of conbercept after vitrectomy', 'interventionNames': ['Drug: passive Anti-VEGF (conbercept) use']}], 'interventions': [{'name': 'proactive Anti-VEGF (conbercept) use', 'type': 'DRUG', 'description': 'preventive intravitreal injection of conbercept 2 weeks after vitrectomy, and repeat at 5 weeks and 8 weeks if either of the following is present: intravitreal VEGF concentration at 2 weeks postop is higher than 100 pg/ml, or clinical presentation of DME, VH or NVG.', 'armGroupLabels': ['group 1 (proactive use of conbercept after vitrectomy)']}, {'name': 'passive Anti-VEGF (conbercept) use', 'type': 'DRUG', 'description': 'No intravitreal injection of conbercept is used until the patient present with postoperative DME, VH, NVG', 'armGroupLabels': ['group 2 (passive use of conbercept after vitrectomy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijin Chen, Dr.', 'role': 'CONTACT', 'phone': '86-010-82266359'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Huijin Chen, Dr.', 'role': 'CONTACT', 'email': 'chjdoc@aliyun.com', 'phone': '86-010-82266359'}], 'overallOfficials': [{'name': 'Huijin Chen, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Chen Huijin', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}