Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-24 @ 9:41 AM
Study NCT ID:
NCT02194634
Status:
UNKNOWN
Last Update Posted:
2016-01-06
First Post:
2014-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C527363', 'term': 'KH902 fusion protein'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}, {'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-16', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.', 'timeFrame': 'Baseline and every month, up to 12 months'}, {'measure': 'Mean change from baseline BCVA between treatment group and controlled group', 'timeFrame': 'Baseline and every month, up to 12 months'}, {'measure': 'Change from baseline in visual acuity distribution of treatment group and controlled group', 'timeFrame': 'Month 6, month 12'}, {'measure': 'The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group', 'timeFrame': 'Month 6, month 12'}], 'primaryOutcomes': [{'measure': 'Mean change from baseline in best corrected visual acuity (BCVA) at month 12', 'timeFrame': 'Baseline and month 12', 'description': 'To compare mean change from baseline BCVA between treatment group and controlled group at month 12.'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline in central retinal thickness (CRT) between two groups', 'timeFrame': 'Baseline and month 12', 'description': 'To compare mean change from baseline CRT between two groups at month 12.'}, {'measure': 'Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection', 'timeFrame': '12 months', 'description': 'To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '34001667', 'type': 'DERIVED', 'citation': 'Liu K, Wang H, He W, Ye J, Song Y, Wang Y, Liu X, Wu Z, Chen S, Fan K, Liu Y, Zhang F, Li Z, Liu L, Zhang J, Zhang X, Ye J, Liang X, Li X, Ke X, Wu Q, Li J, Tao S, Wang X, Rosenfeld P, Heier JS, Kaiser P, Xu X. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol. 2022 Oct;106(10):1436-1443. doi: 10.1136/bjophthalmol-2020-318690. Epub 2021 May 17.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients sign informed consent, and are willing and able to comply with all the follow-ups;\n2. Age ≥ 18 years , both genders;\n3. Diagnosis of type 1 or type 2 diabetes mellitus;\n4. Serum HbA1c ≤ 10%;\n5. Study eye must meet the following criteria:\n\n * Visual acuity impairment caused by DME with involving foveal;\n * BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);\n * Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.\n * Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);\n * Refractive media opacities and miosis have no effect on the fundus examination.\n6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).\n\nExclusion Criteria:\n\n1. Active infectious ocular inflammation in either eye;\n2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;\n3. Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;\n4. Iris neovascularization in the study eye;\n5. Uncontrolled glaucoma, or history of glaucoma surgery;\n6. Aphakia in the study eye;\n7. History of vitrectomy in the study eye;\n8. History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;\n9. Liver, kidney dysfunction;\n10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.'}, 'identificationModule': {'nctId': 'NCT02194634', 'briefTitle': 'Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Biotech Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'KHSWKH902010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conbercept treatment group', 'description': 'Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.', 'interventionNames': ['Drug: Conbercept', 'Other: Sham laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laser treatment group', 'description': 'Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.', 'interventionNames': ['Other: Sham injection', 'Procedure: Laser']}], 'interventions': [{'name': 'Conbercept', 'type': 'DRUG', 'description': 'Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.', 'armGroupLabels': ['Conbercept treatment group']}, {'name': 'Sham injection', 'type': 'OTHER', 'description': 'Sham intravitreal injection at first month, then repeated as needed.', 'armGroupLabels': ['Laser treatment group']}, {'name': 'Laser', 'type': 'PROCEDURE', 'description': 'Laser treatment at first month, then repeated as needed.', 'armGroupLabels': ['Laser treatment group']}, {'name': 'Sham laser', 'type': 'OTHER', 'description': 'Sham laser at first month, then repeated as needed.', 'armGroupLabels': ['Conbercept treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'COMPLETED', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100083', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuling Liu, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tongren hospital affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400038', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaojun Chen, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southwest Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Ye, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Daping Hospital, Research Institute of Surgery Third Military Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao ling Liang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center , Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ke Fan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eye hospital of Henan province', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430070', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanping Song, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wuhan General Hospital of Guangzhou Military', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '214002', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhifeng Wu, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Wuxi No.2 People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '110034', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei He, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'He eye hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xun Xu, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kun Liu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renji hospital shanghai jiaotong university school of medcine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710032', 'city': 'Xian', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yusheng Wang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xijing Hospital'}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junjun Zhang, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300070', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhi qing Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eye center of Tianjin mendical university', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoling Liu, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Affiliated Eye Hospital of WMC', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Junjie Ye, professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xun Xu, professor', 'role': 'CONTACT', 'phone': '86-21-63240090'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kanghong Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}