Treatment History, Demographic Characteristics, Clinical Characteristics, and Early Treatment Patterns of Patients Who Received Brolucizumab for Neovascular Age-related Macular Degeneration: IRIS Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,457
- 试验地点
- 1
- 主要终点
- Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
研究概览
简要总结
This was a retrospective cohort study to assess the treatment history, demographic characteristics, clinical characteristics, and early treatment patterns of patients who received brolucizumab for neovascular age-related macular degeneration using IRIS Registry.
详细描述
This was a retrospective cohort study of patients with wet AMD who received brolucizumab. Evidence was generated from the IRIS registry to describe patient treatment histories, demographic and clinical characteristics, and early treatment patterns.
Setting and study population:
IRIS Registry EHR data from 10/08/2018 to the 03/31/2020 from patients with wet AMD who initiated brolucizumab were analyzed.
Identification period of the index date: The patients fulfilling the selection criteria identified during the period from 10/08/2019 to 03/31/2020.
Index date: Defined as the date of the earliest brolucizumab injection.
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
- •Patients with ≥1 brolucizumab injection
- •Diagnosis of wet AMD (ICD-10: H35.3210, H35.3211, H35.3212, H35.3213, H35.3220, H35.3221, H35.3222, H35.3223, H35.3230, H35.3231, H35.3232, H35.3233, H35.3290, H35.3291, H35.3292, and H35.3293) on the index date
排除标准
- •There were no exclusion criteria
研究组 & 干预措施
Brolucizumab
Participants received brolucizumab injection during the index period
干预措施: Brolucizumab (Drug)
结局指标
主要结局
Number of patients eyes with wet AMD that switched to another anti-VEGF agent (switchers) after initiation of brolucizumab within 4 months
时间窗: Up to 4 months post brolucizumab injection
To describe anti-VEGF treatment status (naive or switcher) in patients with wet AMD who initiated brolucizumab
次要结局
- Age information(Index date)
- Gender information(Index date)
- Number of participants: Regions(12-month period prior to index)
- Number of participants: Insurance type(12-month period prior to index)
- Number of participants: Laterality(12-month period prior to index)
- Number of participants: Concurrent eye disease(12-month period prior to index)
- Number of participants: Provider specialty(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Encounter location (practice location)(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Eye location of brolucizumab injections(12-month period prior to index)
- Index Visual acuity (VA)(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of participants: Race(12-month period prior to index)
- Wet AMD diagnosis for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Visual acuity of the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of prior anti-VEGF treatments(12-month period prior to index)
- Type of prior anti-VEGF treatment among switchers to brolucizumab(12-month period prior to index)
- Prior anti-VEGF treatment sequence(12-month period prior to index)
- Number of prior anti-VEGF injections received prior to brolucizumab index date(12-month period prior to index)
- Injection intervals for the eyes that had received anti-VEGF injections prior to index(12-month period prior to index)
- The first injection interval after switch compared to last injection interval with a prior treatment(Up to 4 months post index date)
- Type of anti-VEGF agent initiated after switching from index brolucizumab(First 3 months after switching from index brolucizumab)
- Anti-VEGF treatment status for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Type of treatment for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
- The number of prior anti-VEGF treatments for the fellow eye(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of brolucizumab injections received per study eye(Up to 4 months post index date)
- The last injection interval(Up to 4 months post index date)