Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-28 @ 6:33 PM
Study NCT ID:
NCT03154892
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2017-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097807', 'term': 'Intracameral Injection'}, {'id': 'D058449', 'term': 'Intravitreal Injections'}], 'ancestors': [{'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-21', 'studyFirstSubmitDate': '2017-05-07', 'studyFirstSubmitQcDate': '2017-05-14', 'lastUpdatePostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NVI/NVA', 'timeFrame': '1 week and 1 month after operation', 'description': 'Changes in extent of iris or angle neovascularization'}], 'secondaryOutcomes': [{'measure': 'IOP', 'timeFrame': '1 week and 1 month after operation', 'description': 'Changes in Intraocular pressure'}, {'measure': 'BCVA', 'timeFrame': '1 week and 1 month after operation', 'description': 'Changes in best corrected visual acuity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Glaucoma']}, 'referencesModule': {'references': [{'pmid': '35083234', 'type': 'DERIVED', 'citation': 'Bai L, Wang Y, Liu X, Zheng Y, Wang W, He N, Tariq F, Wang F, Zhang S. The Optimization of an Anti-VEGF Therapeutic Regimen for Neovascular Glaucoma. Front Med (Lausanne). 2022 Jan 10;8:766032. doi: 10.3389/fmed.2021.766032. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.', 'detailedDescription': 'The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，Its role in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic retinopathy has been described. The intravitreal injection of anti-VEGF agent has shown its therapeutic potential for the early stage of NVG, but not for the late stage. Intracameral injection maybe used as an alternative way for administration. Investigators aim to evaluate the efficacy and safety of intracameral and intravitreal injection of conbercept for the treatment of NVG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of neovascular glaucoma (Stage 1-2-3)\n* Individuals who are ages 20-80 years old; male or female of chinese\n* Visual acuity of light perception or better in the study eye\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide signed informed consent\n\nExclusion Criteria:\n\n* Use of intraocular anti-VEGF agents in the study eye in the past 3 months.\n* Active ocular or periocular infection in the study eye\n* Uncontrolled Blood Pressure\n* Thromboembolism\n* Congestive Heart Failure\n* Renal Failure\n* History of myocardial infarction\n* History of Stroke\n* Pregnant or breast-feeding women\n* Participation in another simultaneous medical investigator or trial'}, 'identificationModule': {'nctId': 'NCT03154892', 'briefTitle': 'The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma', 'organization': {'class': 'OTHER', 'fullName': "Second Affiliated Hospital of Xi'an Jiaotong University"}, 'officialTitle': 'The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma', 'orgStudyIdInfo': {'id': 'Conbercept Injection'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracameral injection', 'description': 'Intracameral injection of conbercept for the treatment of NVG', 'interventionNames': ['Procedure: Intracameral injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravitreal injection', 'description': 'Intravitreal injection of conbercept for the treatment of NVG', 'interventionNames': ['Procedure: Intravitreal injection']}], 'interventions': [{'name': 'Intracameral injection', 'type': 'PROCEDURE', 'description': 'Intracameral Conbercept injection for the treatment of NVG', 'armGroupLabels': ['Intracameral injection']}, {'name': 'Intravitreal injection', 'type': 'PROCEDURE', 'description': 'Intravitreal Conbercept injection for the treatment of NVG', 'armGroupLabels': ['Intravitreal injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710004', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Ling Bai, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second affiliated hospital of Xian Jiaotong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}