Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-26 @ 5:41 PM
Study NCT ID:
NCT07106268
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aqueous Humor Proteome in Retinal Vein Occlusion With Macular Edema
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Aqueous humor'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-07-30', 'studyFirstSubmitQcDate': '2025-07-30', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central retinal thickness', 'timeFrame': 'March 2023 - June 2024', 'description': 'The Heidelberg Optical Coherence Tomography scanner was used to detect the central retinal thickness in patients'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'March 2023 - June 2024', 'description': 'BCVA was measured using logarithm of the minimum angle of resolution (LogMAR) chart'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Vein Occlusion']}, 'descriptionModule': {'briefSummary': 'the goal of this observational study is to the find the molecular mechanisms underlying the prognosis process of Retinal vein occlusion in patients with retinal vein occlusion . The main question it aims to answer is:\n\nWhat are the changes in protein in the aqueous humor during treatment in patients who are sensitive to anti-VEGF drug therapy?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with retinal vein occlusion with macular edema', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystic or diffuse edema in the macular area, retinal vein tortuous dilation with hemorrhage\n* Optical coherence tomography (OCT) examination showed that the macular area was raised, edema and thickened\n* Monocular disease, baseline central retinal thickness (CRT) ≥ 250mm\n* Intravitreal injection, laser photocoagulation and blood circulation and blood stasis removal drugs were not treated before surgery\n* The patient had normal blood pressure, negative urine protein, normal liver and kidney function, and normal electrocardiogram\n\nExclusion Criteria:\n\n* Patients with fluorescein fundus angiography (FFA) showing a large area (10 optic disc areas) without perfusion requiring retinal photocoagulation\n* Patients with chronic dacryocystitis, glaucoma, cataract, severe proliferative vitreoretinopathy or vitreous hemorrhage, epi macular membrane or macular ischemia, diabetic retinopathy, age-related macular degeneration, ocular trauma and other diseases\n* Intravitreal therapy or laser photocoagulation with corticosteroids or anti-VEGF drugs within three months before the study'}, 'identificationModule': {'nctId': 'NCT07106268', 'briefTitle': 'Aqueous Humor Proteome in Retinal Vein Occlusion With Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Eye Hospital'}, 'officialTitle': 'Aqueous Humor Proteome Analysis in Conbercept-treated Retinal Vein Occlusion With Macular Edema', 'orgStudyIdInfo': {'id': 'MR-12-24-035937'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with central retinal vein occlusion', 'description': 'Received three injections of the anti-VEGF drug Conbercept'}, {'label': 'Patients with branch retinal vein occlusion', 'description': 'Received three injections of the anti-VEGF drug Conbercept'}, {'label': 'Cataract patients without other eye diseases and other chronic diseases', 'description': 'Undergo cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '300384', 'city': 'Tianjin', 'state': 'Province', 'country': 'China', 'facility': 'Tianjin medical university eye hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Chuanzhen Zheng', 'investigatorAffiliation': 'Tianjin Medical University Eye Hospital'}}}}