Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Agerelated Macular Degeneration (AMD) Who Received Anti-VEGF Agents (IRIS Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331,541
- 试验地点
- 1
- 主要终点
- Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
研究概览
简要总结
In this cross-sectional study of patients with wet AMD who received ≥1 anti-VEGF injection (excluding brolucizumab), evidence was generated to describe the period prevalence of specific ocular AEs. The study was conducted using the IRIS Registry, and all results were based on the study period from 01/01/2019 to 12/31/2019.
详细描述
This was a retrospective cohort study of eyes in adult patients with a diagnosis of wet AMD who were treated with anti-VEGF agents from 01/01/2019 to 12/31/2019.
IRIS Registry data from 01/01/2019 to 12/31/2019 for patients with a diagnosis of wet AMD who were treated with ≥1 anti-VEGF agent (excluding brolucizumab) were included.
- Identification period: Patients fulfilling the selection criteria during the period from 01/01/2019 to 12/31/2019 were identified
- Index date: 01/01/2019
- Study Period: 01/01/2019 to 12/31/2019
- Pre-index period: 01/01/2018 to 12/31/2018
- Post-index period: 01/01/2019 to 12/31/2019
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥1 International Classification of Diseases, Clinical Modification-9/10 CM (ICD- 9/10) code for wet AMD in 2019
- •≥1 Healthcare Common Procedure Coding System (HCPCS) code (J code) or National Drug Code (NDC) code for treatment with an anti-VEGF agent (excluding brolucizumab) in 2019
- •≥18 years old in 2019
- •≥2 wet AMD-related office visits in 2019
排除标准
- •Patient eyes that received >1 type of anti-VEGF treatment on the same date
- •Patient eyes that did not have laterality any time during 2018-2019
- •Treatment with brolucizumab during 2019
结局指标
主要结局
Number of patients with Intraocular Inflammation (IOI) Adverse events (AEs) who were treated with anti-VEGF agents
时间窗: earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019
Period prevalence of IOI in patients with wet AMD who were treated with anti- VEGF agents (excluding brolucizumab) over a one-year period in 2019 was assessed.
次要结局
- Number of patients with Laterality of wet Age-related macular degeneration (AMD)(Index date (defined as the date of first injection - 01/01/2019))
- Age(earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019)
- Gender information(earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019)
- Number of patient eyes treated with anti-VEGF agent(Index date (defined as the date of first injection - 01/01/2019))
- Number of patients with other ocular AEs in patients with wet AMD who were treated with anti-VEGF agents (excluding brolucizumab)(over a one-year period from 01/012019 to 31/12/2019)
- Number of patients at various Patient Region(earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019)
- Number of patients with Insurance type(earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019)
- Number of anti-VEGF injections(over a one-year period from 01/012019 to 31/12/2019)
- Number of patient eyes with the Provider specialty on date of first anti-VEGF injection(earliest claim of anti-VEGF injection over a one-year period from 01/012019 to 31/12/2019)