Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
1 other identifier
observational
4,000
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 16, 2017
February 1, 2017
1.7 years
February 8, 2017
February 13, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
New Adverse Reactions
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
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
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
1 year
Secondary Outcomes (11)
Other Ocular Adverse Events
1 year
Other Ocular Adverse Events
1 year
Non-ocular Adverse Events
1 year
Non-ocular Adverse Events
1 year
Adverse Events of Special Interest(AESI)
1 year
- +6 more secondary outcomes
Eligibility Criteria
All medical academies will initially identify whether patients are enrolled based on baseline registration information.
You may qualify if:
- The condition that informed consent has been freely given prior to research-related procedures;
- Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.
You may not qualify if:
- 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;
- Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Baoji People'S Hospital
Baoji, China
Beijing Aier-Intech Eye Hospital
Beijing, China
Beijing Tongren Hospital, Cmu
Beijing, China
Eye Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The 306Th Hospital of Pla
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Sichuan Provincial People's Hospital
Chengdu, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The third people's Hospital of Dalian
Dalian, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
The Second Affiliated Hospital of ZhejiangUniversity School of Medicine
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong
Hong Kong, China
Shandong Eye Hospital
Jilancun, China
Shandong Provincal Hospital
Jilancun, China
The Second Hospital of Jilin University
Jiling, China
Kashgar First People's Hospital
Kashgar, China
Lanzhou University Second Hospital
Lanzhou, China
Central Hospital of Mudanjiang Forestry
Mudanjiang, China
Jiangsu Province Hospital of CTM
Nanjing, China
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Ningbo Eye Hospital
Ningbo, China
Ningxia People'S Hospital
Ningxia, China
Pingdingshan People'S Hospital No.1
Pingdingshan, China
The First Hospital of Qiqihar
Qiqihar, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine
Shanghai, China
Shanghai General Hospital
Shanghai, China
Shanghai Tongji Hospital
Shanghai, China
Shenyang the Fourth Hospital of People
Shenyang, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, China
Peking University Shenzhen Hospital
Shenzhen, China
Shenzhen Eye Hospital
Shenzhen, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Eye Hospital
Taiyuan, China
Tianjin Medical University Eye Hospital
Tianjin, China
No.474 Hospital of Pla
Ürümqi, China
Wuhan General Hospital of Pla
Wuhan, China
Wuxi NO.2 People's Hospital
Wuxi, China
Tangdu Hospital
Xi'an, China
Xi'An No.4 Hospitla
Xi'an, China
Xijing Hospital
Xi'an, China
Hebeisheng Eye Hospital
Xingtai, China
The First People's Hospital of Xuzhou
Xuzhou, China
Zhongshan Ophthalmic Center, Sun Yay-Sen University
Zhongshan, China
Study Officials
- PRINCIPAL INVESTIGATOR
Ningli Wang
BEIJING TONGREN HOSPITAL, CMU
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 16, 2017
Study Start
October 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
February 16, 2017
Record last verified: 2017-02