DATA-INSIGHT: Data Analysis for Treatment Assessment and Evaluation of New Sources for Evidence Generation in German Healthcare System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50,000
- 试验地点
- 1
- 主要终点
- incidence of nAMD, DME and RVO of FDZ and FDPG in Germany
研究概览
简要总结
The main goal of this study is to find out how common certain eye diseases are in Germany and how they have changed over time. The diseases being studied are:
nAMD (neovascular age-related macular degeneration): a condition that affects the central part of the retina and can cause vision loss in older adults.
DME (diabetic macular edema): a swelling in the central part of the retina caused by diabetes, which can also lead to vision problems.
RVO (retinal vein occlusion): a blockage of the veins in the retina, which can cause sudden vision loss.
Researchers will look at data collected from 2009 to 2024 to see how often these diseases occur (incidence) and how many people have them at a given time (prevalence). They will use two large sets of health data from Germany, called FDZ and FDGP.
The main question is: How do the numbers of new and existing cases of nAMD, DME, and RVO compare between the two data sources (FDZ and FDGP) in Germany from 2009 to 2024? The study also wants to find out if factors like age, other health problems, and medications affect how common these eye diseases are.
Another goal is to see how many people with these eye diseases are treated with a type of medicine called anti-VEGF, which is used to slow down or stop vision loss.
In summary, this study will help us understand how these eye diseases affect people in Germany, how they are treated, and whether different groups of people are more likely to get them.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •At least one diagnosis of nAMD, DME and RVO in the timeframe 01 JAN 2009 until 31 DEC 2024
- •nAMD patients aged ≥ 50 years
- •DME patients aged ≥18 years
- •RVO patients aged ≥18 years
- •Participants living in Germany covered by statutory health insurance or private health insurance
排除标准
- 未提供
研究组 & 干预措施
DME cohort
participants diagnosed with DME
干预措施: anti-VEGF medication (Drug)
RVO cohort
participants diagnosed with RVO
干预措施: anti-VEGF medication (Drug)
nAMD cohort
participants diagnosed with nAMD
干预措施: anti-VEGF medication (Drug)
结局指标
主要结局
incidence of nAMD, DME and RVO of FDZ and FDPG in Germany
时间窗: 1 Jan 2009 - 31 Dec 2024
one-year incidence rate is defined as all new patients fulfilling the inclusion and exclusion criteria in each data repository in the respective year for the first time compared to all patients in the repository in the given year.
prevalence of nAMD, DME and RVO in Germany
时间窗: 1 Jan 2009 - 31 Dec 2024
one-year prevalence rate is defined as the proportion of patients fulfilling inclusion and exclusion criteria in each data repository in the respective year PLUS patients identified in any previous year in relation to all patients in the repository in the given year.
次要结局
- incidence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources(1 Jan 2009 - 31 Dec 2024)
- prevalence of nAMD, DME and RVO of FDZ and FDPG in Germany influenced by demographics, comorbidities, medications and data sources(1 Jan 2009 - 31 Dec 2024)
- Number of patients with nAMD, DME, and RVO treated with anti-VEGF medications(1 Jan 2009 - 31 Dec 2024)
- Proportion of patients with nAMD, DME, and RVO treated with anti-VEGF medications(1 Jan 2009 - 31 Dec 2024)