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临床试验/NCT05111743
NCT05111743已完成不适用

Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 9,261 人开始时间: 2020年6月17日最近更新:
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
9,261
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 Komodo Healthcare Map.

详细描述

Komodo Healthcare Map claims data from 08-Oct-2016 to the date of most recent 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 were identified during the period from 08-Oct-2019 to 30-Apr-2020.
  • Index date: Defined as the date of the earliest brolucizumab injection during the index period.
  • Study Period: The period from 08-Oct-2016 to the most recent data extraction date (05-Jun-2020).

o Note since 05-Jun-2020 was the date data was pulled, claims data from recent months (e.g. May) may be incomplete (relative to the final DB state) as well.

  • Pre-index period: The period 36 months prior to the index date

o Note: Data within 36 months prior to the index date will be used to assess baseline characteristics.

  • Post-index period: The period of 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

入选标准

  • 未提供

排除标准

  • 未提供

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

  • Number of patient eyes with Intraocular inflammation(12 and 6 months 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 Provider specialty(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Number of patient eyes with the Last injection inetrval(60 months prior to index ( 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))
  • Age(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Gender information(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Number of patients at various Patient Region(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Number of patients with Laterality of wet Age-related macular degeneration (AMD)(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • 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 patients with Laterality of any Age-related macular degeneration (AMD)(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Number of patient eyes with previous ocular surgeries or procedures(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 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 patients with Insurance type(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Number of patient eyes with Systemic inflammation / auto-immune history (in total and at the event level)(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 eyes treated with brolucizumab(Index date defined as the date of the earliest brolucizumab injection during the index period (from 08-Oct-2019 to 30-Apr-2020))
  • Time from last anti-VEGF injection to index date(60 months prior to index ( 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)
  • History of other IOI and endophthalmitis due to infections or other underlying disease(36, 12 and 6 months 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 different prior anti-VEGF agents(60 months prior to index ( 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))
  • Number of patient eyes with systemic comorbidities(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 Concomitant systemic medications (chronic use)(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 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 the history of ocular inflammation (includes IOIs or panuveitis or endophthalmitis relevant to safety evaluation)(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 treatment status(60 months prior to index ( index date defined as the date of first brolucizumab injection))
  • Number of patient eyes with prior anti-VEGF agents (total, per anti-VEGF agent)(60 months prior to index ( 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))
  • Type of exam performed(30 days before or on first brolucizumab injection (index date))
  • Number of patient eyes with Anti-VEGF treatment-naive vs prior-treated(60 months prior to index ( index date defined as the date of first brolucizumab injection))
  • Duration of last anti-VEGF treatment (total, per anti-VEGF agent)(60 months prior to index ( index date defined as the date of first brolucizumab injection))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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