Wet Age-related Macular Degeneration (wAMD)NCT03054818
Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
An observational study of Wet Age-related Macular Degeneration (wAMD), run by Chengdu Kanghong Biotech Co., Ltd. at 49 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wet Age-related Macular Degeneration (wAMD)
- How many people
- 4,000 participants
- Where
- 49 sitesChina
- Study dates
- Oct 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All medical academies will initially identify whether patients are enrolled based on baseline registration information.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
China49 sites, 49 recruiting
- Not yet recruiting
Baoji People'S Hospital
Baoji
Wuqiang Shan
- Recruiting
Beijing Aier-Intech Eye Hospital
Beijing
Wei Gu
- Not yet recruiting
Beijing Tongren Hospital, Cmu
Beijing
Wenbin Wei
- Not yet recruiting
Eye Hospital, China Academy of Chinese Medical Sciences
Beijing
Hong Qing
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Yong Zhong
- Not yet recruiting
Peking University Third Hospital
Beijing
Hongliang Dou
- Not yet recruiting
The 306Th Hospital of Pla
Beijing
Ling Luo
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing
Dachuan Liu
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu
Jie Zhong
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Xiyuan Zhou
- Not yet recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
Xiang Ma
- Not yet recruiting
The third people's Hospital of Dalian
Dalian
Zhongming Liu
- Not yet recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Xiangyin Sha
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang
Xian Wang
- Not yet recruiting
The Second Affiliated Hospital of ZhejiangUniversity School of Medicine
Hangzhou
Ke Yao
- Not yet recruiting
Anhui Provincial Hospital
Hefei
Gengjie Ke
- Not yet recruiting
JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong
Hong Kong
Haoyu Cheng
- Not yet recruiting
Shandong Eye Hospital
Jilancun
Gongqiang Yuan
- Not yet recruiting
Shandong Provincal Hospital
Jilancun
Bojun Zhao
- Not yet recruiting
The Second Hospital of Jilin University
Jiling
Guanfang Shu
- Not yet recruiting
Kashgar First People's Hospital
Kashgar
Ruixing Ding
- Not yet recruiting
Lanzhou University Second Hospital
Lanzhou
Wenfang Zhang
- Not yet recruiting
Central Hospital of Mudanjiang Forestry
Mudanjiang
Shuqing Zhu
- Not yet recruiting
Jiangsu Province Hospital of CTM
Nanjing
Wei Wei
- Not yet recruiting
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning
Siming Zheng
- Not yet recruiting
Ningbo Eye Hospital
Ningbo
Jianshu Yuan
- Not yet recruiting
Ningxia People'S Hospital
Ningxia
Xunlun Sheng
- Not yet recruiting
Pingdingshan People'S Hospital No.1
Pingdingshan
Yong Li
- Not yet recruiting
The First Hospital of Qiqihar
Qiqihar
Hang Lu
- Not yet recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Xi Sheng
- Not yet recruiting
Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine
Shanghai
Jianming Tang
- Not yet recruiting
Shanghai General Hospital
Shanghai
Shuqing Yu
- Not yet recruiting
Shanghai Tongji Hospital
Shanghai
Ao Rong
- Not yet recruiting
Shenyang the Fourth Hospital of People
Shenyang
Hailing Wang
- Not yet recruiting
The Fourth Affiliated Hospital of China Medical University
Shenyang
Fan Zhang
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen
Jianhong Huang
- Not yet recruiting
Shenzhen Eye Hospital
Shenzhen
Qingshan Chen
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
Jingxue Ma
- Not yet recruiting
Shanxi Eye Hospital
Taiyuan
Yading Jia
- Not yet recruiting
Tianjin Medical University Eye Hospital
Tianjin
Xiaorong Li
- Not yet recruiting
No.474 Hospital of Pla
Ürümqi
Xiaowei Gao
- Not yet recruiting
Wuhan General Hospital of Pla
Wuhan
Yanping Song
- Not yet recruiting
Wuxi NO.2 People's Hospital
Wuxi
Zhifeng Wu
- Not yet recruiting
Tangdu Hospital
Xi'an
Hong Yan
- Not yet recruiting
Xi'An No.4 Hospitla
Xi'an
Chunning Lei
- Not yet recruiting
Xijing Hospital
Xi'an
Yusheng Wang
- Not yet recruiting
Hebeisheng Eye Hospital
Xingtai
Minglian Zhang
- Not yet recruiting
The First People's Hospital of Xuzhou
Xuzhou
Suyan Li
- Not yet recruiting
Zhongshan Ophthalmic Center, Sun Yay-Sen University
Zhongshan
Xiaoling Liang
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: 1 year
Common Ocular Adverse Events
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
Secondary outcomes (11)
Other Ocular Adverse Events
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.
Measured: 1 year
Other Ocular Adverse Events
To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
Non-ocular Adverse Events
To observe the type, incidence and severity of non-ocular adverse events during the study
Measured: 1 year
Non-ocular Adverse Events
To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
Adverse Events of Special Interest(AESI)
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
Measured: 1 year
Adverse Events of Special Interest(AESI)
To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
SAE
To observe the type, incidence and severity of all severe adverse events during the study
Measured: 1 year
SAE
To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
Adverse Events Related to Intravitreal Injection Practices
To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.
Measured: 1 year
Adverse Events of Special Population
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.
Measured: 1 year
Adverse Events of Special Population
To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startOct 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related Macular Degeneration (wAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ningli Wang, Principal investigator, BEIJING TONGREN HOSPITAL, CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054818
- Sponsor's protocol ID
- RG01N-1578-1.0
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word
- ClinicalTrials.gov ID
- NCT03054818
- Acronym / sponsor ID
- RG01N-1578-1.0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All medical academies will initially identify whether patients are enrolled based on baseline registration information.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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;
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.
Common Ocular Adverse Events
Time frame: 1 year
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
11 secondary outcomes
Other Ocular Adverse Events
Time frame: 1 year
Other Ocular Adverse Events
Time frame: 1 year
Non-ocular Adverse Events
Time frame: 1 year
Non-ocular Adverse Events
Time frame: 1 year
Adverse Events of Special Interest(AESI)
Time frame: 1 year
Adverse Events of Special Interest(AESI)
Time frame: 1 year
SAE
Time frame: 1 year
SAE
Time frame: 1 year
Adverse Events Related to Intravitreal Injection Practices
Time frame: 1 year
Adverse Events of Special Population
Time frame: 1 year
Adverse Events of Special Population
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ningli Wang principal investigator
BEIJING TONGREN HOSPITAL, CMU
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration (wAMD), run by Chengdu Kanghong Biotech Co., Ltd. at 49 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ningli Wang (010-58265922, wningli@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Adverse Reactions (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.