Wet Age-related Macular Degeneration (wAMD) Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 4000 |
| Est. completion date | June 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | 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 | Hongkong | |
| China | Shandong Eye Hospital | Jilan | |
| China | Shandong Provincal Hospital | Jilan | |
| China | The Second Hospital of Jilin University | Jiling | |
| China | Kashgar First People's Hospital | Kashi | |
| 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 | Wuhan General Hospital of Pla | Wuhan | |
| China | No.474 Hospital of Pla | Wulumuqi | |
| China | Wuxi NO.2 People's Hospital | Wuxi | |
| China | Tangdu Hospital | Xi'an | |
| China | Xi'An No.4 Hospitla | Xi'an | |
| China | Xijing Hospital | Xian | |
| China | Hebeisheng Eye Hospital | Xingtai | |
| China | The First People's Hospital of Xuzhou | Xuzhou | |
| China | Zhongshan Ophthalmic Center, Sun Yay-Sen University | Zhongshan |
| Lead Sponsor | Collaborator |
|---|---|
| Chengdu Kanghong Biotech Co.,Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | Common Ocular Adverse Events | To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy. | 1 year | |
| Secondary | 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. | 1 year | |
| Secondary | Other Ocular Adverse Events | To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy. | 1 year | |
| Secondary | Non-ocular Adverse Events | To observe the type, incidence and severity of non-ocular adverse events during the study | 1 year | |
| Secondary | Non-ocular Adverse Events | To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy. | 1 year | |
| Secondary | 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 | 1 year | |
| Secondary | Adverse Events of Special Interest(AESI) | To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy. | 1 year | |
| Secondary | SAE | To observe the type, incidence and severity of all severe adverse events during the study | 1 year | |
| Secondary | SAE | To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy. | 1 year | |
| Secondary | 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. | 1 year | |
| Secondary | 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. | 1 year | |
| Secondary | Adverse Events of Special Population | To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy. | 1 year |