NCT05082415已完成不适用
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,456
- 试验地点
- 1
- 主要终点
- Number of patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
研究概览
简要总结
This study was a retrospective cohort study of patients to assess the early insights into real-world safety among wet AMD patients initiating brolucizumab. Evidence was generated to describe their patient characteristics and clinical outcomes. The study was conducted using the IRIS Registry.
详细描述
IRIS Registry EHR data from patients with wet AMD who initiated brolucizumab were analyzed in this study.
Identification period of the index date (index period): The patients fulfilling the selection criteria was identified
- Index date: Defined as the date of the earliest brolucizumab injection
- Study Period: The period from the first patient eye exposure to brolucizumab to the last follow-up recorded
- Pre-index period: The period 36 months prior to the index date. Data within 36 months prior to the index date will be used to assess baseline characteristics.
- Post-index period: The period 180 days after the index date
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 Healthcare Common Procedure Coding System (HCPCS) code (J code) or EMR note for treatment with brolucizumab during the index period (date of earliest code or EMR note = index date)
- •≥18 years old on the index date
- •≥1 Current Procedural Terminology (CPT) code for intravitreal administration on the index date
- •≥1 International Classification of Diseases, Clinical Modification-9/10 (ICD-9/10) code for wet AMD in the 36 months prior to or on the index date
- •o Note: Off-label use of brolucizumab is not expected given payer access restrictions in the US.
- •≥1 follow-up visit after the index date
- •≥1 VA assessment on the index date or within 90 days prior to the index date
排除标准
- •Use of brolucizumab prior to 10/8/2019 (e.g. clinical trials)
- •Unknown laterality of the index eye on the index date
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 patient eyes with an Intraocular Inflammation (IOI) event during the first 6 months
时间窗: Up to 6 months post brolucizumab injection
To assess IOI events observed after starting treatment with brolucizumab
次要结局
- Age(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Gender information(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of patients at various Patient Region(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of patients with Insurance type(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of patients with Laterality of wet Age-related macular degeneration (AMD)(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Race/Ethnicity of the participants (patient level and eye level)(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of eyes with the concurrent eye disease(Within 180 days prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with cataract status(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with Concomitant ocular medications(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with the history of ocular inflammation(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with prior Intraocular Inflammation (IOI) and/or prior Retinal vascular occlusion (RO)(12 months prior to the index date ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with the Provider specialty(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of patient eyes with the previous ocular surgeries or procedures(6 months prior to the index date ( index date defined as the date of first brolucizumab injection))
- Time since wet Age-related macular degeneration (AMD) diagnosis(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Time since any Age-related macular degeneration (AMD) diagnosis(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Time from last anti-VEGF injection to index date (among switchers)(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of ocular adverse events (AEs)(Post-index period defined as the 180 days following therapy initiation, excluding index date)
- Number of eyes treated with brolucizumab(At the brolucizumab index date defined as the date of first brolucizumab injection)
- Number of patient eyes with Visual Acuity (VA) reading(At the brolucizumab index date defined as the date of first brolucizumab injection with lookback of 365 days)
- Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of patient eyes with the prior treatment status(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of different prior anti-VEGF agents(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Number of prior anti-VEGF injections(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
- Duration of last anti-VEGF treatment(36-month period prior to the index date (inclusive of the index date) ( index date defined as the date of first brolucizumab injection))
研究者
研究点 (1)
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