Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-01-22 @ 12:31 AM
Study NCT ID:
NCT03054818
Status:
UNKNOWN
Last Update Posted:
2017-02-16
First Post:
2017-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2017-02-08', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New Adverse Reactions', 'timeFrame': '1 year', 'description': 'To observe the type, incidence and severity of new adverse reactions in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study;'}, {'measure': 'Common Ocular Adverse Events', 'timeFrame': '1 year', 'description': 'To observe the type, incidence and severity of common ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study, including: 1) bleeding at injection site; 2) increased intraocular pressure (IOP); 3) conjunctival congestion; 4) conjunctivitis; 5) decreased visual sensitivity; and 6) muscae volitantes.'}, {'measure': 'Common Ocular Adverse Events', 'timeFrame': '1 year', 'description': "To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy."}], 'secondaryOutcomes': [{'measure': 'Other Ocular Adverse Events', 'timeFrame': '1 year', 'description': 'To observe the type, incidence and severity of other ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study.'}, {'measure': 'Other Ocular Adverse Events', 'timeFrame': '1 year', 'description': "To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy."}, {'measure': 'Non-ocular Adverse Events', 'timeFrame': '1 year', 'description': 'To observe the type, incidence and severity of non-ocular adverse events during the study'}, {'measure': 'Non-ocular Adverse Events', 'timeFrame': '1 year', 'description': "To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy."}, {'measure': 'Adverse Events of Special Interest(AESI)', 'timeFrame': '1 year', 'description': 'To observe the incidence and severity of adverse events of special interest (AESI) during the study, including: 1) retinal detachment; 2) retinal tears; 3) retinal pigment epithelial detachment; 4) retinal pigment epithelium tears; 5) geographic atrophy; 6) endophthalmitis; 7) arterial thromboembolic events (ATEs); and 8) hypertension'}, {'measure': 'Adverse Events of Special Interest(AESI)', 'timeFrame': '1 year', 'description': "To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy."}, {'measure': 'SAE', 'timeFrame': '1 year', 'description': 'To observe the type, incidence and severity of all severe adverse events during the study'}, {'measure': 'SAE', 'timeFrame': '1 year', 'description': "To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy."}, {'measure': 'Adverse Events Related to Intravitreal Injection Practices', 'timeFrame': '1 year', 'description': 'To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.'}, {'measure': 'Adverse Events of Special Population', 'timeFrame': '1 year', 'description': 'To observe the incidence and severity of adverse events of special population during the study,including children and adolescents (aged under 18), and pregnant women.'}, {'measure': 'Adverse Events of Special Population', 'timeFrame': '1 year', 'description': "To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy."}]}, 'conditionsModule': {'conditions': ['Wet Age-related Macular Degeneration (wAMD)']}, 'descriptionModule': {'briefSummary': 'This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner. Safety information about patients who have received intravitreal injection of Conbercept Ophthalmic Injection in medical institutions involved in the study during research will be actively monitored without intervening in diagnosis and treatment. All patients enrolled will be followed up for one year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All medical academies will initially identify whether patients are enrolled based on baseline registration information.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The condition that informed consent has been freely given prior to research-related procedures;\n2. Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.\n\nExclusion Criteria:\n\n1. Patients who have been on any of other anti-VEGF drugs systematically or locally, including but not limited to bevacizumab, ranibizumab and aflibercept, 90 days before enrollment;\n2. Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.'}, 'identificationModule': {'nctId': 'NCT03054818', 'briefTitle': 'Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Biotech Co., Ltd.'}, 'officialTitle': 'Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word', 'orgStudyIdInfo': {'id': 'RG01N-1578-1.0'}}, 'contactsLocationsModule': {'locations': [{'city': 'Baoji', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wuqiang Shan', 'role': 'CONTACT'}], 'facility': "Baoji People'S Hospital", 'geoPoint': {'lat': 34.36775, 'lon': 107.23705}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Gu', 'role': 'CONTACT'}], 'facility': 'Beijing Aier-Intech Eye Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenbin Wei', 'role': 'CONTACT'}], 'facility': 'Beijing Tongren Hospital, Cmu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Qing', 'role': 'CONTACT'}], 'facility': 'Eye Hospital, China Academy of Chinese Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Zhong', 'role': 'CONTACT'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongliang Dou', 'role': 'CONTACT'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ling Luo', 'role': 'CONTACT'}], 'facility': 'The 306Th Hospital of Pla', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dachuan Liu', 'role': 'CONTACT'}], 'facility': 'Xuanwu Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Zhong', 'role': 'CONTACT'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chongqing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiyuan Zhou', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Dalian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Ma', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Dalian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongming Liu', 'role': 'CONTACT'}], 'facility': "The third people's Hospital of Dalian", 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangyin Sha', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guiyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xian Wang', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Hangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Yao', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of ZhejiangUniversity School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hefei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gengjie Ke', 'role': 'CONTACT'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hong Kong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haoyu Cheng', 'role': 'CONTACT'}], 'facility': 'JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Jilancun', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gongqiang Yuan', 'role': 'CONTACT'}], 'facility': 'Shandong Eye Hospital', 'geoPoint': {'lat': 23.16332, 'lon': 106.86939}}, {'city': 'Jilancun', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bojun Zhao', 'role': 'CONTACT'}], 'facility': 'Shandong Provincal Hospital', 'geoPoint': {'lat': 23.16332, 'lon': 106.86939}}, {'city': 'Jiling', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanfang Shu', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 38.56667, 'lon': 101.78333}}, {'city': 'Kashgar', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ruixing Ding', 'role': 'CONTACT'}], 'facility': "Kashgar First People's Hospital", 'geoPoint': {'lat': 39.46718, 'lon': 75.98675}}, {'city': 'Lanzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenfang Zhang', 'role': 'CONTACT'}], 'facility': 'Lanzhou University Second Hospital', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Mudanjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqing Zhu', 'role': 'CONTACT'}], 'facility': 'Central Hospital of Mudanjiang Forestry', 'geoPoint': {'lat': 44.54804, 'lon': 129.62594}}, {'city': 'Nanjing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Wei', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Hospital of CTM', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Siming Zheng', 'role': 'CONTACT'}], 'facility': "The People'S Hospital of Guangxi Zhuang Autonomous Region", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Ningbo', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianshu Yuan', 'role': 'CONTACT'}], 'facility': 'Ningbo Eye Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Ningxia', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xunlun Sheng', 'role': 'CONTACT'}], 'facility': "Ningxia People'S Hospital"}, {'city': 'Pingdingshan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Li', 'role': 'CONTACT'}], 'facility': "Pingdingshan People'S Hospital No.1", 'geoPoint': {'lat': 33.73091, 'lon': 113.31554}}, {'city': 'Qiqihar', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hang Lu', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Qiqihar', 'geoPoint': {'lat': 47.33922, 'lon': 123.96154}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xi Sheng', 'role': 'CONTACT'}], 'facility': 'Rui Jin Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianming Tang', 'role': 'CONTACT'}], 'facility': 'Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqing Yu', 'role': 'CONTACT'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ao Rong', 'role': 'CONTACT'}], 'facility': 'Shanghai Tongji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hailing Wang', 'role': 'CONTACT'}], 'facility': 'Shenyang the Fourth Hospital of People', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fan Zhang', 'role': 'CONTACT'}], 'facility': 'The Fourth Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Shenzhen', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianhong Huang', 'role': 'CONTACT'}], 'facility': 'Peking University Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shenzhen', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingshan Chen', 'role': 'CONTACT'}], 'facility': 'Shenzhen Eye Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Shijiazhuang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingxue Ma', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Taiyuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yading Jia', 'role': 'CONTACT'}], 'facility': 'Shanxi Eye Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Tianjin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaorong Li', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University Eye Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaowei Gao', 'role': 'CONTACT'}], 'facility': 'No.474 Hospital of Pla', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Wuhan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanping Song', 'role': 'CONTACT'}], 'facility': 'Wuhan General Hospital of Pla', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhifeng Wu', 'role': 'CONTACT'}], 'facility': "Wuxi NO.2 People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': "Xi'an", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Yan', 'role': 'CONTACT'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunning Lei', 'role': 'CONTACT'}], 'facility': "Xi'An No.4 Hospitla", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yusheng Wang', 'role': 'CONTACT'}], 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Xingtai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Minglian Zhang', 'role': 'CONTACT'}], 'facility': 'Hebeisheng Eye Hospital', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'city': 'Xuzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Suyan Li', 'role': 'CONTACT'}], 'facility': "The First People's Hospital of Xuzhou", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'city': 'Zhongshan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Liang', 'role': 'CONTACT'}], 'facility': 'Zhongshan Ophthalmic Center, Sun Yay-Sen University', 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'centralContacts': [{'name': 'Ningli Wang', 'role': 'CONTACT', 'email': 'wningli@vip.163.com', 'phone': '010-58265922'}], 'overallOfficials': [{'name': 'Ningli Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BEIJING TONGREN HOSPITAL, CMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kanghong Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}