Incidence of Retinal Vasculitis Among Patients Receiving Aflibercept: A US Real-World Evidence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290,000
- 试验地点
- 1
- 主要终点
- Incidence of RV events
研究概览
简要总结
This study will describe and estimate the incidence of Retinal Vasculitis (RV) events among patients and patient eyes receiving aflibercept intravitreal (IVT) (Eylea®, aflibercept 2mg) therapy in US clinical practice.
The main objective is to describe demographic and clinical characteristics of patients receiving aflibercept 2mg injections, to estimate the incidence of RV and RV plus Intraocular Inflammation (IOI) following aflibercept 2mg injections and to describe characteristics of RV cases.
详细描述
This study is purely descriptive using US claims data from Komodo Healthcare Map.
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
- 未提供
排除标准
- •Aflibercept injections with unspecified laterality will be excluded
- •Aflibercept injections from individuals aged <18 years or those with unknown age on the injection date will be excluded
- •Patient-eyes with a diagnosis of RV in the same eye as the aflibercept injection or with unspecified laterality within 12 months (365 days) prior to index date (inclusive), as defined in the protocol
- •Patient-eyes that do not meet the continuous enrollment requirement will be excluded
- •Aflibercept injections will be excluded if there is ≥1 other anti-VEGF injection administered on the same date
- •NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
Study Patients
Patients ≥ 18 years of age, who received aflibercept 2mg IVT during the study period
干预措施: aflibercept 2mg (Drug)
结局指标
主要结局
Incidence of RV events
时间窗: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Incidence of RV plus IOI events
时间窗: During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years
Incidence will be defined as the number of events during the at-risk period divided by the total number of injections, identified using international classification of diseases (ICD-10) diagnosis codes
Clinical characteristics: Number of participants with different retinal disease diagnosis categories
时间窗: 12 months prior to the index date
Retinal disease categories: nAMD, DME, DR w/o DME, or macular edema following retinal vein occlusion \[MEfRVO\])
Demographics characteristics
时间窗: 12 months prior to the index date
Demographics include: sex, age, race/ethnicity, insurance, geographic area
Clinical characteristics: Mean Charlson Comorbidity Index (CCI) score
时间窗: 12 months prior to the index date
The Charlson Comorbidity Index (CCI) is a method used to categorize comorbidities based on International Classification of Diseases (ICD) diagnosis codes. A score of 0 indicates that no comorbidities were found, while higher scores correspond to increased predicted mortality
Clinical characteristics: Summary of comorbidities reported as number of participants with different categories
时间窗: 12 months prior to the index date
Different comorbidity categories: Syphilis, Herpesviridae, Toxoplasmosis, Tuberculosis, Systemic lupus erythematosus, Multiple sclerosis, Behçet's disease, Cardiovascular disease, Hypertension, Diabetes, Hypercholesterolemia
Clinical characteristics: Number of participants with prior anti-VEGF treatment
时间窗: 12 months prior to the index date
次要结局
- Incidence of RV plus RO(During the 60-Day at-risk period following aflibercept 2 mg IVT, up to approximately 7 years)