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Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）

Sponsor
Chengdu Kanghong Biotech Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03054818
Collaborator
(none)
4,000
Enrollment
49
Locations
20
Duration (Months)
81.6
Patients Per Site
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word
    Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Jun 1, 2018
    Anticipated Study Completion Date :
    Jun 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. New Adverse Reactions [1 year]

      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;

    2. Common Ocular Adverse Events [1 year]

      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.

    3. Common Ocular Adverse Events [1 year]

      To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

    Secondary Outcome Measures

    1. Other Ocular Adverse Events [1 year]

      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.

    2. Other Ocular Adverse Events [1 year]

      To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

    3. Non-ocular Adverse Events [1 year]

      To observe the type, incidence and severity of non-ocular adverse events during the study

    4. Non-ocular Adverse Events [1 year]

      To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

    5. Adverse Events of Special Interest(AESI) [1 year]

      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

    6. Adverse Events of Special Interest(AESI) [1 year]

      To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.

    7. SAE [1 year]

      To observe the type, incidence and severity of all severe adverse events during the study

    8. SAE [1 year]

      To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.

    9. Adverse Events Related to Intravitreal Injection Practices [1 year]

      To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.

    10. Adverse Events of Special Population [1 year]

      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.

    11. Adverse Events of Special Population [1 year]

      To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The condition that informed consent has been freely given prior to research-related procedures;

    2. Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.

    Exclusion Criteria:

    1. 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;

    2. Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baoji People'S Hospital Baoji China
    2 Beijing Aier-Intech Eye Hospital Beijing China
    3 Beijing Tongren Hospital, Cmu Beijing China
    4 Eye Hospital, China Academy of Chinese Medical Sciences Beijing China
    5 Peking Union Medical College Hospital Beijing China
    6 Peking University Third Hospital Beijing China
    7 The 306Th Hospital of Pla Beijing China
    8 Xuanwu Hospital Capital Medical University Beijing China
    9 Sichuan Provincial People's Hospital Chengdu China
    10 The Second Affiliated Hospital of Chongqing Medical University Chongqing China
    11 The First Affiliated Hospital of Dalian Medical University Dalian China
    12 The third people's Hospital of Dalian Dalian China
    13 The Second Affiliated Hospital of Guangzhou Medical University Guangzhou China
    14 The Affiliated Hospital of Guizhou Medical University Guiyang China
    15 The Second Affiliated Hospital of ZhejiangUniversity School of Medicine Hangzhou China
    16 Anhui Provincial Hospital Hefei China
    17 JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong Hongkong China
    18 Shandong Eye Hospital Jilan China
    19 Shandong Provincal Hospital Jilan China
    20 The Second Hospital of Jilin University Jiling China
    21 Kashgar First People's Hospital Kashi China
    22 Lanzhou University Second Hospital Lanzhou China
    23 Central Hospital of Mudanjiang Forestry Mudanjiang China
    24 Jiangsu Province Hospital of CTM Nanjing China
    25 The People'S Hospital of Guangxi Zhuang Autonomous Region Nanning China
    26 Ningbo Eye Hospital Ningbo China
    27 Ningxia People'S Hospital Ningxia China
    28 Pingdingshan People'S Hospital No.1 Pingdingshan China
    29 The First Hospital of Qiqihar Qiqihar China
    30 Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai China
    31 Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine Shanghai China
    32 Shanghai General Hospital Shanghai China
    33 Shanghai Tongji Hospital Shanghai China
    34 Shenyang the Fourth Hospital of People Shenyang China
    35 The Fourth Affiliated Hospital of China Medical University Shenyang China
    36 Peking University Shenzhen Hospital Shenzhen China
    37 Shenzhen Eye Hospital Shenzhen China
    38 The Second Hospital of Hebei Medical University Shijiazhuang China
    39 Shanxi Eye Hospital Taiyuan China
    40 Tianjin Medical University Eye Hospital Tianjin China
    41 Wuhan General Hospital of Pla Wuhan China
    42 No.474 Hospital of Pla Wulumuqi China
    43 Wuxi NO.2 People's Hospital Wuxi China
    44 Tangdu Hospital Xi'an China
    45 Xi'An No.4 Hospitla Xi'an China
    46 Xijing Hospital Xian China
    47 Hebeisheng Eye Hospital Xingtai China
    48 The First People's Hospital of Xuzhou Xuzhou China
    49 Zhongshan Ophthalmic Center, Sun Yay-Sen University Zhongshan China

    Sponsors and Collaborators

    • Chengdu Kanghong Biotech Co., Ltd.

    Investigators

    • Principal Investigator: Ningli Wang, BEIJING TONGREN HOSPITAL, CMU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chengdu Kanghong Biotech Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03054818
    Other Study ID Numbers:
    • RG01N-1578-1.0
    First Posted:
    Feb 16, 2017
    Last Update Posted:
    Feb 16, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Feb 16, 2017