Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05222633
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2021-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-VEGF in Real-world
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}, {'id': 'C533178', 'term': 'aflibercept'}, {'id': 'C527363', 'term': 'KH902 fusion protein'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2021-12-25', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '1 year', 'description': 'LogMAR visual acuity'}, {'measure': 'Central subfield thickness', 'timeFrame': '1 year', 'description': 'he central subfield is defined as the circular area 1 mm in diameter centered around the center point of the fovea'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Edema', 'Diabetic Macular Edema', 'Choroidal Neovascular Membrane', 'Non-proliferative Diabetic Retinopathy', 'Retinal Vein Occlusion', 'Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-vascular endothelial growth factor therapy drugs. In the current study, the primary aim is to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.', 'detailedDescription': 'Anti-vascular endothelial growth factor therapy is the major intervention for treating ischemic retina diseases, including neovascular age-related macular edema, diabetic macula edema/non-proliferative diabetic retinopathy / proliferative diabetic retinopathy, retinal vein occlusions related macular edema, and choroidal neovascularization secondary to multiple retinal diseases. According to FDA and China Food and Drug Administration, Ranibizumab, Aflibercept, and Conbercept are major types of anti-VEGF drugs. In the current study, the primary aim is to aim to observe the visual acuity, anatomy effect of anti-vascular endothelial growth factor therapy in the real-world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neovascular age-related macular edema (nAMD), diabetic macula edema (DME)/non-proliferative diabetic retinopathy (NPDR)/ proliferative diabetic retinopathy (PDR), retinal vein occlusions related macular edema, and choroidal neovascular (CNV) secondary to multiple retinal diseases.\n* Undergo intravitreal anti-VEGF therapy\n\nExclusion Criteria:\n\n* unable to receive OCT examination\n* Severe corneal opacity, cataract that affect OCT examination'}, 'identificationModule': {'nctId': 'NCT05222633', 'briefTitle': 'Anti-VEGF in Real-world', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Observation of Anti-vascular Endothelial Growth Factor Therapy in Exudative Age-related Macular Degeneration, Proliferative Diabetic Retinopathy, Macular Edema, and Choroidal Neovascularization.', 'orgStudyIdInfo': {'id': 'Anti-VEGF in real-world'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neovascular age-related macular edema', 'description': 'Patients with new-onset and recurrent Neovascular age-related macular edema.', 'interventionNames': ['Drug: Ranibizumab', 'Drug: Aflibercept', 'Drug: Conbercept']}, {'label': 'Diabetic macula edema', 'description': 'Patients with new-onset and recurrent diabetic macula edema', 'interventionNames': ['Drug: Ranibizumab', 'Drug: Aflibercept', 'Drug: Conbercept']}, {'label': 'Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy', 'description': 'Patients with new-onset and recurrent non-proliferative diabetic retinopathy/proliferative diabetic retinopathy', 'interventionNames': ['Drug: Ranibizumab', 'Drug: Aflibercept', 'Drug: Conbercept']}, {'label': 'Retinal vein occlusions', 'description': 'Patients with new-onset and recurrent retinal vein occlusions', 'interventionNames': ['Drug: Ranibizumab']}, {'label': 'Choroidal neovascularization', 'description': 'Patients with new-onset and recurrent choroidal neovascularization', 'interventionNames': ['Drug: Ranibizumab', 'Drug: Aflibercept', 'Drug: Conbercept']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'description': 'Ranibizumab 0.5mg/0.05ml intravitreal injection', 'armGroupLabels': ['Choroidal neovascularization', 'Diabetic macula edema', 'Neovascular age-related macular edema', 'Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy', 'Retinal vein occlusions']}, {'name': 'Aflibercept', 'type': 'DRUG', 'description': 'Aflibercept 2.0mg/0.05ml intravitreal injection', 'armGroupLabels': ['Choroidal neovascularization', 'Diabetic macula edema', 'Neovascular age-related macular edema', 'Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy']}, {'name': 'Conbercept', 'type': 'DRUG', 'description': 'Conbercept 0.5mg/0.05ml intravitreal injection', 'armGroupLabels': ['Choroidal neovascularization', 'Diabetic macula edema', 'Neovascular age-related macular edema', 'Non-proliferative diabetic retinopathy/proliferative diabetic retinopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wen-Bin Wei, MD', 'role': 'CONTACT', 'email': 'weiwenbintr@163.com'}, {'name': 'Wen-Bin Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wen-Bin Wei', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wenbin Wei, MD', 'role': 'CONTACT', 'email': 'weiwenbintr@163.com', 'phone': '010-58269523'}], 'overallOfficials': [{'name': 'Wenbin Wei, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Tongren Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenbin Wei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Wenbin Wei', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}