Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
- Conditions
- Wet Age-related Macular Degeneration (wAMD)
- Registration Number
- NCT03054818
- Lead Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;
Common Ocular Adverse Events 1 year To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
- Secondary Outcome Measures
Name Time Method Other Ocular Adverse Events 1 year To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Adverse Events of Special Interest(AESI) 1 year To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.
SAE 1 year To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.
Non-ocular Adverse Events 1 year To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
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.
Adverse Events of Special Population 1 year To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.
Trial Locations
- Locations (49)
Beijing Tongren Hospital, Cmu
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
The Second Affiliated Hospital of ZhejiangUniversity School of Medicine
🇨🇳Hangzhou, China
Kashgar First People's Hospital
🇨🇳Kashi, China
Central Hospital of Mudanjiang Forestry
🇨🇳Mudanjiang, China
Pingdingshan People'S Hospital No.1
🇨🇳Pingdingshan, China
Jiangsu Province Hospital of CTM
🇨🇳Nanjing, 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
Shenzhen Eye Hospital
🇨🇳Shenzhen, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, China
Tianjin Medical University Eye Hospital
🇨🇳Tianjin, China
Wuhan General Hospital of Pla
🇨🇳Wuhan, China
The First People's Hospital of Xuzhou
🇨🇳Xuzhou, China
Baoji People'S Hospital
🇨🇳Baoji, China
Beijing Aier-Intech Eye Hospital
🇨🇳Beijing, China
Eye Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
The 306Th Hospital of Pla
🇨🇳Beijing, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, China
The third people's Hospital of Dalian
🇨🇳Dalian, China
Anhui Provincial Hospital
🇨🇳Hefei, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong
🇨🇳Hongkong, China
Shandong Eye Hospital
🇨🇳Jilan, China
Shandong Provincal Hospital
🇨🇳Jilan, China
The Second Hospital of Jilin University
🇨🇳Jiling, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, China
The People'S Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
Ningbo Eye Hospital
🇨🇳Ningbo, China
Ningxia People'S Hospital
🇨🇳Ningxia, China
The First Hospital of Qiqihar
🇨🇳Qiqihar, 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
Shanxi Eye Hospital
🇨🇳Taiyuan, China
No.474 Hospital of Pla
🇨🇳Wulumuqi, China
Wuxi NO.2 People's Hospital
🇨🇳Wuxi, China
Tangdu Hospital
🇨🇳Xi'an, China
Xijing Hospital
🇨🇳Xian, China
Xi'An No.4 Hospitla
🇨🇳Xi'an, China
Hebeisheng Eye Hospital
🇨🇳Xingtai, China
Zhongshan Ophthalmic Center, Sun Yay-Sen University
🇨🇳Zhongshan, China