NCT06779773 A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
| NCT ID | NCT06779773 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Astellas Pharma Global Development, Inc. |
| Condition | Geographic Atrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-01-22 |
| Primary Completion | 2030-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-01-22 with a primary completion date of 2030-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 * 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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Astellas Pharma Global Development, Inc.
Frequently Asked Questions
Who can join the NCT06779773 clinical trial?
This trial is open to participants of all sexes, studying Geographic Atrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06779773 currently recruiting?
Yes, NCT06779773 is actively recruiting participants. Contact the research team at Astellas.registration@astellas.com for enrollment information.
Where is the NCT06779773 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, Scottsdale, United States, Encino, United States and 11 additional locations.
Who is sponsoring the NCT06779773 clinical trial?
NCT06779773 is sponsored by Astellas Pharma Global Development, Inc.. The principal investigator is Medical Director at Astellas Pharma Global Development, Inc.. The trial plans to enroll 500 participants.