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

Launched by ASTELLAS PHARMA GLOBAL DEVELOPMENT, INC. · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a treatment called avacincaptad pegol, also known as Izervay™, is used in real-life settings for people with geographic atrophy, a serious form of age-related macular degeneration (AMD). AMD affects the part of the eye that helps you see clearly, and geographic atrophy leads to the loss of cells in that area, which can cause permanent vision loss. The trial aims to gather information about how effective this treatment is and any side effects that may occur while people are receiving it.

To participate, individuals must have geographic atrophy in one or both eyes and have decided to receive treatment with avacincaptad pegol. They will undergo regular eye exams and complete surveys about their eye health at the start of treatment and then every six months for the first two years, and annually afterward. Participants can stay in the study for up to three to five years, depending on when they start. This trial is open to anyone who meets the eligibility criteria, regardless of age or gender, and their doctor will guide their treatment decisions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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).
• Exclusion Criteria:
• * 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 at enrollment/baseline visit
• • 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 study eye. Note: Patients who have received or are receiving ACP in the fellow eye 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.