A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 117
- 主要终点
- Number of ACP injections
研究概览
简要总结
This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.
Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.
This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor have decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).
People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for around 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes
- •Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment
- •Patient willingness to complete the patient reported outcome (PRO).
排除标准
- •Patients who have any contraindication or are not eligible for treatment with ACP, including the following:
- •Active ocular or peri-ocular infection in either eye
- •Active, suspected intraocular inflammation in either eye
- •Hypersensitive to ACP or to any ingredient in the formulation
- •Patients currently participating in an investigational program with interventions outside of routine clinical practice.
- •Patients who have received ACP in the eye being considered for enrollment. Note: Patients who have received or are receiving ACP in the fellow eye at baseline are eligible to be included in the study.
- •Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.
研究组 & 干预措施
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay
干预措施: Avacincaptad pegol (ACP) (Drug)
结局指标
主要结局
Number of ACP injections
时间窗: Up to 61 Months
The number of ACP injections.
Dose of ACP injection
时间窗: Up to 61 Months
The dose of each ACP injection.
Duration of treatment
时间窗: Up to 61 Months
The duration of treatment will be calculated as the difference between the date of the last injection and the date of the first injection plus 31 days (as the next injection would be expected at least 30 days after the last one).
Annual frequency of ACP injection
时间窗: Up to 61 Months
The annual frequency of ACP injections will be calculated as the total number of injections divided by the treatment duration in years.
Reasons for discontinuation of treatment with ACP
时间窗: Up to 61 Months
The reasons for discontinuation of treatment with ACP will be recorded.
Duration of the treatment interval
时间窗: Up to 61 Months
The treatment interval is defined as mean number of days between injections, if a study eye receives more than 1 injection.
Site characteristics
时间窗: Day 1
Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban).
Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay
时间窗: Day 1
Characteristics of interest will be recorded.
次要结局
- Number of participants with Adverse Events (AEs)(Up to 61 Months)
- Number of participants with Serious Adverse Events (SAEs)(Up to 61 Months)
- Number of participants with Treatment Emergent Adverse Events (TEAEs)(Up to 61 Months)
- Number of participants with Adverse Event of Special Interest (AESI)(Up to 61 Months)
- Number of Participants maintaining vision(Up to 61 Months)
- Time to vision loss using various thresholds(Up to 61 Months)
- Time to thresholds associated with ability to drive(Up to 61 Months)
- Participant's reading speed(Up to 61 Months)