NCT05639660招募中不适用
Aflibercept Observational Study for the Clinical Use of PCV in China, Polycentric, Observational, Retrospective-prospective Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change of Mean BCVA from baseline at the month 3, 6, 12
研究概览
简要总结
The purpose of this study is to evaluate the overall treatment characteristics and efficacy of Aflibercept in the treatment of PCV in China through a multicenter, observational, prospective-retrospective study. This study is a long-term follow-up cohort, plans to unite a total of 30 hospitals in different regions of the China to enroll 1000 PCV patients.
Main evaluation indicators: To observe the changes in visual acuity (BCVA) in PCV patients treated with Aflibercept to evaluate the effectiveness of the treatment.
详细描述
Primary Study Objective(s) To provide overall treatment characteristics of aflibercept in PCV treatment Secondary Study Objective(s)
- To describe the treatment regimens of aflibercept treatment on PCV in clinical practice.
- To evaluate effectiveness of aflibercept treatment on PCV including vision gain (BCVA) and anatomic improvement (CRT, Polyps regression, Polyps inactivity, and PED)
- To explore the relative factors of aflibercept treatment effectiveness.
- To describe patients' tolerance to anti-VEGF and PDT treatment.
- To collect safety information with aflibercept treatment in a wider population setting
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, gender, unilateral or bilateral onset
- •Treatment-experienced or treatment-naïve patients diagnosed with PCV after ICGA examination
- •Signed informed consent, able to long-term follow-up
- •PCV patients previously treated with aflibercept were enrolled as retrospective cases, and PCV patients previously treated with other anti-VEGF, at least 1 month since the last treatment
排除标准
- •Patients with anterior segment (including iris and angle) neovascularization or neovascular glaucoma
- •Received oral or intravenous antiangiogenic drugs within 180 days prior to the screening visit
- •The study eye has a history of idiopathic or autoimmune uveitis
- •Study eyes with active ocular inflammation or evidence of infectious blepharitis, corneal inflammation, scleritis, or conjunctivitis
- •The patient has a coagulation disorder or is taking oral warfarin, Plavix (clopidogrel) and other similar anticoagulation drugs.
- •The patient is receiving treatment for severe systemic infection
- •Patients with uncontrolled blood pressure (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg when the subject is sitting)
- •Cerebrovascular accident and/or myocardial infarction within 180 days prior to the screening visit
- •Patients with renal insufficiency undergoing renal dialysis, renal failure requiring dialysis or renal transplantation
- •The investigator believes that based on the history of other diseases, metabolic dysfunction, physical examination results or clinical laboratory results, patients have a disease or condition that will increase the risk for complications from treatment
- •Pregnant or lactating women; women of childbearing potential with positive pregnancy test results at baseline or not receiving pregnancy test; postmenopausal women must have been amenorrhea for at least 12 months to not be considered fertile
- •Participated in any drug (except vitamins and minerals) or device therapy study within 30 days prior to the screening visit
- •The patient has received other anti-VEGF therapy within 30 days
- •Other patients deemed necessary to be excluded by the investigator
结局指标
主要结局
Change of Mean BCVA from baseline at the month 3, 6, 12
时间窗: Through study completion, 1 year
Routine International standard visual acuity chart, best corrected visual acuity
Mean treatment pattern of aflibercept in PCV treatment
时间窗: Through study completion, 1 year
To describe the mean treatment pattern of aflibercept in PCV treatment
次要结局
- Inactive polyp evaluation by OCTA at month 3, 6, 12(Through study completion, 1 year)
- Proportion of patients with inactivity polyps at month 3, 6, 12(Through study completion, 1 year)
- Mean of treatment interval and number of injections at month 12(Through study completion, 1 year)
- Change in CRT from baseline at month 3, 6, 12(Through study completion, 1 year)
- Proportion of patients with complete regression of polyps at month 3, 6, 12(Through study completion, 1 year)
- Proportion of patients with dry retina at month 3, 6 and 12(Through study completion, 1 year)
- Proportion of patients with PED regression at month 3, 6 and 12(Through study completion, 1 year)
- Proportion of patients with each treatment regimen(Through study completion, 1 year)
研究者
研究点 (1)
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