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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu Kanghong Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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