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

February 13, 2017 updated by: Chengdu Kanghong Biotech Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baoji, China
        • Not yet recruiting
        • Baoji People's Hospital
        • Contact:
          • Wuqiang Shan
      • Beijing, China
        • Not yet recruiting
        • Peking University Third Hospital
      • Beijing, China
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
          • Yong Zhong
      • Beijing, China
        • Not yet recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:
          • Dachuan Liu
      • Beijing, China
        • Recruiting
        • Beijing Aier-Intech Eye Hospital
        • Contact:
          • Wei Gu
      • Beijing, China
        • Not yet recruiting
        • Beijing Tongren Hospital, CMU
        • Contact:
          • Wenbin Wei
      • Beijing, China
        • Not yet recruiting
        • Eye Hospital, China Academy of Chinese Medical Sciences
        • Contact:
          • Hong Qing
      • Beijing, China
        • Not yet recruiting
        • The 306th Hospital of PLA
        • Contact:
          • Ling Luo
      • Chengdu, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
      • Chongqing, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Xiyuan Zhou
      • Dalian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Xiang Ma
      • Dalian, China
        • Not yet recruiting
        • The Third People'S Hospital of Dalian
        • Contact:
          • Zhongming Liu
      • Guangzhou, China
        • Not yet recruiting
        • the Second Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Xiangyin Sha
      • Guiyang, China
        • Not yet recruiting
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, China
        • Not yet recruiting
        • The Second Affiliated Hospital of ZhejiangUniversity School of Medicine
      • Hefei, China
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
          • Gengjie Ke
      • Hongkong, China
        • Not yet recruiting
        • Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
        • Contact:
          • Haoyu Cheng
      • Jilan, China
        • Not yet recruiting
        • Shandong Eye Hospital
        • Contact:
          • Gongqiang Yuan
      • Jilan, China
        • Not yet recruiting
        • Shandong Provincal Hospital
        • Contact:
          • Bojun Zhao
      • Jiling, China
        • Not yet recruiting
        • The Second Hospital of Jilin University
        • Contact:
          • Guanfang Shu
      • Kashi, China
        • Not yet recruiting
        • Kashgar First People's Hospital
        • Contact:
          • Ruixing Ding
      • Lanzhou, China
        • Not yet recruiting
        • Lanzhou University Second Hospital
      • Mudanjiang, China
        • Not yet recruiting
        • Central Hospital of Mudanjiang Forestry
        • Contact:
          • Shuqing Zhu
      • Nanjing, China
        • Not yet recruiting
        • Jiangsu Province Hospital of CTM
      • Nanning, China
        • Not yet recruiting
        • The people's hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • Siming Zheng
      • Ningbo, China
        • Not yet recruiting
        • Ningbo Eye Hospital
        • Contact:
          • Jianshu Yuan
      • Ningxia, China
        • Not yet recruiting
        • Ningxia People's Hospital
        • Contact:
          • Xunlun Sheng
      • Pingdingshan, China
        • Not yet recruiting
        • Pingdingshan People's Hospital No.1
      • Qiqihar, China
        • Not yet recruiting
        • The First Hospital of Qiqihar
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Tongji Hospital
        • Contact:
          • Ao Rong
      • Shanghai, China
        • Not yet recruiting
        • Shanghai General Hospital
        • Contact:
          • Shuqing Yu
      • Shanghai, China
        • Not yet recruiting
        • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Xi Sheng
      • Shanghai, China
        • Not yet recruiting
        • Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine
        • Contact:
          • Jianming Tang
      • Shenyang, China
        • Not yet recruiting
        • Shenyang the Fourth Hospital of People
        • Contact:
          • Hailing Wang
      • Shenyang, China
        • Not yet recruiting
        • the Fourth Affiliated Hospital of China Medical University
        • Contact:
          • Fan Zhang
      • Shenzhen, China
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Jianhong Huang
      • Shenzhen, China
        • Not yet recruiting
        • Shenzhen Eye Hospital
        • Contact:
          • Qingshan Chen
      • Shijiazhuang, China
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
      • Taiyuan, China
        • Not yet recruiting
        • Shanxi Eye Hospital
      • Tianjin, China
        • Not yet recruiting
        • Tianjin Medical University Eye Hospital
      • Wuhan, China
        • Not yet recruiting
        • Wuhan General Hospital of Pla
        • Contact:
          • Yanping Song
      • Wulumuqi, China
        • Not yet recruiting
        • No.474 Hospital of Pla
        • Contact:
          • Xiaowei Gao
      • Wuxi, China
        • Not yet recruiting
        • Wuxi No.2 People's Hospital
        • Contact:
          • Zhifeng Wu
      • Xi'an, China
        • Not yet recruiting
        • Tangdu Hospital
        • Contact:
          • Hong Yan
      • Xi'an, China
        • Not yet recruiting
        • Xi'An No.4 Hospitla
        • Contact:
          • Chunning Lei
      • Xian, China
        • Not yet recruiting
        • Xijing Hospital
      • Xingtai, China
        • Not yet recruiting
        • Hebeisheng Eye Hospital
        • Contact:
          • Minglian Zhang
      • Xuzhou, China
        • Not yet recruiting
        • The First People's Hospital of Xuzhou
        • Contact:
          • Suyan Li
      • Zhongshan, China
        • Not yet recruiting
        • Zhongshan Ophthalmic Center, Sun Yay-Sen University
        • Contact:
          • Xiaoling Liang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All medical academies will initially identify whether patients are enrolled based on baseline registration information.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New Adverse Reactions
Time Frame: 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;
1 year
Common Ocular Adverse Events
Time Frame: 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.
1 year
Common Ocular Adverse Events
Time Frame: 1 year
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Ocular Adverse Events
Time Frame: 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.
1 year
Other Ocular Adverse Events
Time Frame: 1 year
To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year
Non-ocular Adverse Events
Time Frame: 1 year
To observe the type, incidence and severity of non-ocular adverse events during the study
1 year
Non-ocular Adverse Events
Time Frame: 1 year
To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year
Adverse Events of Special Interest(AESI)
Time Frame: 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
1 year
Adverse Events of Special Interest(AESI)
Time Frame: 1 year
To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.
1 year
SAE
Time Frame: 1 year
To observe the type, incidence and severity of all severe adverse events during the study
1 year
SAE
Time Frame: 1 year
To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year
Adverse Events Related to Intravitreal Injection Practices
Time Frame: 1 year
To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.
1 year
Adverse Events of Special Population
Time Frame: 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.
1 year
Adverse Events of Special Population
Time Frame: 1 year
To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Investigators

  • Principal Investigator: Ningli Wang, Beijing Tongren Hospital, CMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2018

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (ACTUAL)

February 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG01N-1578-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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