A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Condition(s) studied

Investigational drug(s) / intervention(s)

Avacincaptad pegol (ACP): intravitreal injection

Study summary

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.

Eligibility

Primary outcome measure(s)

• Number of ACP injections — Up to 61 Months
  The number of ACP injections.
• Duration of treatment — 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 — 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 — Up to 61 Months
  The reasons for discontinuation of treatment with ACP will be recorded.
• Duration of the treatment interval — 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 — 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 — Day 1
  Characteristics of interest will be recorded.

Trial sites (58)

+ 18 more sites — see the full list on the official registry below.

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