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MinorEnrollment closed, study ongoingTrial sites reduced: 65 → 58 locations · Enrollment target: estimated 500 to confirmed 489 · Eligibility criteria expanded, about 10 words · 1 moreShow 4 more changesShow less
Trial sites reduced: 65 → 58 locations
Enrollment target: estimated 500 to confirmed 489
Eligibility criteria expanded, about 10 words
Secondary endpoints: details revised at 3 of 7 entries
MinorSite details revised at 1 of 65 sitesv34
MinorSite details revised at 1 of 65 sitesv33
MinorSite details revised at 1 of 65 sitesv32
MinorSite details revised at 1 of 65 sitesv31
NotablePrimary and study completion pushed from Jan 31, 2030 to Oct 31, 2030Primary endpoint(s) modified · Enrollment reduced: 1000 → 500 participants · Site details revised at 1 of 65 sitesv30Show 3 more changesShow less
NotableEnrollment target: 1000 to 500Primary and study completion dates: Jan 31, 2030 to Oct 31, 2030 · Primary endpoints: 8 to 7 · Secondary endpoints: 8 to 7 · 2 morev29Show 5 more changesShow less
Primary and study completion dates: Jan 31, 2030 to Oct 31, 2030
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date changed from estimate of Jan 31, 2025 to Jan 22, 2025v2Show 2 more changesShow less
Study sites: 0 to 1
Start date changed from estimate of Jan 31, 2025 to Jan 22, 2025
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.