To Determine Long-term Outcomes, Recurrence Rates, and Treatment Needs in Polypoidal Choroidal Vasculopathy(PCV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 3
- 主要终点
- Long term prognostication
研究概览
简要总结
To determine long-term outcomes, recurrence rates, and treatment needs in Polypoidal Choroidal Vasculopathy (PCV). Specifically, to describe the long-term outcomes, recurrence rates and treatment patterns PCV patients 5 years after first presentation. This study will also evaluate whether polyp closure within the first 12 months of therapy is associated with better long-term visual outcome and will also determine the risk of disease development in the fellow eye
详细描述
The investigators will conduct a non-interventional, observational cohort study to assess the visual outcome of patients who have completed one of three recent randomized controlled trials in Polypoidal Choroidal Vasculopathy (PCV) EVERESTII, PLANET, PCV Treat and Extend (T&E) study. After completion of the randomized controlled trails (2 years for EVEREST II and PLANET; 1 year for T&E study), patients will be released from clinical trial protocol. At approximately 6 years (2019-2024), patients will be contacted by research coordinators and invited to attend a follow-up examination.
Study Design:
Non-interventional, observational, cohort study
Clinical coordinators will contact patients of:
- EVEREST II (2013-2015)
- PLANET (2014-2015)
- PCV T&E (2018-2019) at ~72 +/- 6 months after their initial baseline visits (2019-2024) Study Visits and Procedures Participants will only be expected to attend 1 evaluation clinic which will last approximately 3 hours
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
- •Participants will have completed the previous PCV RCTs: EVEREST II, PLANET and PCV T&E studies
- •Are able to give consent for this follow up study
排除标准
- •No exclusion criteria unless they do not meet the inclusion criteria
结局指标
主要结局
Long term prognostication
时间窗: within 72 months
Long term recurrence rates, correlated baseline characteristics and initial treatment strategies correlated to long term outcomes
次要结局
未报告次要终点
研究者
Gemmy Cheung Chui Ming
Professor
Singapore National Eye Centre