Characterization of Patients With Geographic Atrophy (GA) in the US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68,563
- 试验地点
- 1
- 主要终点
- Change in Visual Acuity (VA) in Participant's Study Eye
研究概览
简要总结
To quantify and describe patients with a Geographic Atrophy (GA) diagnosis in at least one eye, and the progression to neovascular Age-Related Macular Degeneration (including how many receive Anti-VEGF), or to GA (in the fellow eye only).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ≥50 years, with a GA diagnosis in at least one eye, included in the Vestrum database identified during the study period (January 2015 to April 2023).
排除标准
- •Patients without the information of laterality will be excluded.
结局指标
主要结局
Change in Visual Acuity (VA) in Participant's Study Eye
时间窗: From index date of GA diagnosis up to 5 years
Change in visual acuity (VA) in participant's study eye is reported. Study eye is defined as the first eye with the disease, and fellow eye, the participant's second eye. Change in VA was determined by calculating the difference between mean visual acuity (VA) readings at index diagnosis, and mean at another timepoint, assessed yearly for participants with valid VA readings at both timepoints.
Number of Participants Who Developed or Progressed to Age-related Macular Degeneration (wAMD) in the Study Eye
时间窗: From index date of GA diagnosis up to 5 years.
Number of participants who developed or progressed to age-related macular degeneration (wAMD) in the study eye is reported. The criteria used to determine progression through development to wAMD was identifying when ICD (International Classification of Diseases) codes for wAMD were present in the study eye.
Number of Participants Who Developed or Progressed to Geographic Atrophy (GA) in the Fellow Eye
时间窗: From index date of GA diagnosis up to 5 years.
Number of participants who developed or progressed to geographic atrophy (GA) in the fellow eye is reported. For patients diagnosed with GA at baseline, the development of GA in the fellow eye was closely monitored over time, with progress tracked for each year.
Change in Lesion Location for Participants With wAMD in Study Eye
时间窗: From index date of GA diagnosis up to 5 years
Change in lesion location from extrafoveal to subfoveal in participants who developed wAMD in study eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed wAMD in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year.
Change in Lesion Location for Participants With GA in Fellow Eye
时间窗: From index date of GA diagnosis up to 5 years
Change in lesion location from extrafoveal to subfoveal in participants who developed GA in fellow eye is reported. Lesion location was assessed at index diagnosis and at each year, then stratified by whether a patient developed GA in the 5 years post diagnosis. Changes in lesion were calculated as the difference in the number of participants with extrafoveal location at index diagnosis of the study eye, compared to the number of participants with extrafoveal lesion in the study eye at each year.
Occurrence of GA Over Study Period
时间窗: Number of yearly counts of GA from 2018 to 2013, by quarterly average.
Incidence and prevalence of GA over time is reported. This endpoint analyzed the yearly counts of newly diagnosed or prevalent cases to help in understanding the progression of the overall disease.
次要结局
- Retinal Disease-related Outcomes: Number of Visits Per Quarter in a Year(Mean number of quarterly visits from 2019 up to 2023.)
- Retinal Disease-related Outcomes: Number of Anti-VEGF Injections Per Quarter(Mean number of quarterly anti-VEGF injections from 2019 up to 2023.)
- Retinal Disease-related Outcomes: Number of Participants With Ocular Comorbidities by Year of Follow up(Total number of participants with ocular comorbidities were documented from index date up to 5 years.)
- HCRU Outcome: Number of Participants With the Medical Procedure of Corneal Transplant(Total number of participants with corneal transplants were documented from index date up to 5 years.)
- HCRU Outcome: Number of Participants With the Medical Procedure of Incisional Glaucoma Surgery(Total number of participants with incisional glaucoma surgery were documented from index date up to 5 years.)
- HCRU Outcome: Number of Participants With the Medical Procedure of Vitrectomy(Total number of participants with vitrectomy were documented from index date up to 5 years.)