Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-20 @ 3:57 PM
Study NCT ID:
NCT02098720
Status:
UNKNOWN
Last Update Posted:
2014-07-22
First Post:
2014-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-21', 'studyFirstSubmitDate': '2014-03-25', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain', 'timeFrame': '6-month'}], 'secondaryOutcomes': [{'measure': 'mean change in BCVA from baseline', 'timeFrame': '6-month'}, {'measure': 'change from baseline of macular area thickness and other anatomy results', 'timeFrame': '6-month'}, {'measure': 'safety of Conbercept therapy', 'timeFrame': '6-month', 'description': 'To assess incidence of adverse events, incidence of adverse drug reactions etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Very Low Vision Secondary to Wet Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients give fully informed consent and are willing and able to comply with all study procedures.\n2. In the study eye:\n\n There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.\n\n The criterion of active CNV should meet at least one of following three conditions :\n * fresh bleeding;\n * neurosensory detachment showed on optical coherence tomography(OCT);\n * leakage showed on fundus fluorescein angiography (FFA).\n3. BCVA in study eye \\< 19 letters (approximately 20/400 Snellen equivalent).\n\nExclusion Criteria:\n\n1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;\n2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;\n3. History of vitreous hemorrhage within last month;\n4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;\n5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;\n6. History of glaucoma in study eye;\n7. Aphakia (excluding artificial lens) in the study eye.'}, 'identificationModule': {'nctId': 'NCT02098720', 'acronym': 'LAMP', 'briefTitle': 'An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Biotech Co., Ltd.'}, 'officialTitle': 'An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'KHSWKH902009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conbercept', 'description': 'Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results.', 'interventionNames': ['Drug: Conbercept']}], 'interventions': [{'name': 'Conbercept', 'type': 'DRUG', 'armGroupLabels': ['Conbercept']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center,Sun yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kanghong Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}