Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 4,000
- 试验地点
- 49
- 主要终点
- New Adverse Reactions
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
New Adverse Reactions
时间窗: 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
时间窗: 1 year
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
次要结局
- Adverse Events of Special Interest(AESI)(1 year)
- SAE(1 year)
- Other Ocular Adverse Events(1 year)
- Non-ocular Adverse Events(1 year)
- Adverse Events Related to Intravitreal Injection Practices(1 year)
- Adverse Events of Special Population(1 year)