Clinical trial NCT06779773: A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Geographic Atrophy
Macular Degeneration
Keywords: Avacincaptad Pegol
IZERVAY™
Treatment patterns
Safety
Functional Outcomes
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants from both academic and non-academic sites, urban and rural across the US to ensure a heterogenous population that is representative of the US GA secondary to AMD population and reflective of real-world practice patterns.

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 has 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 up to 3 years or up to 5 years, depending on when they start the study.


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.

Primary outcomes:
measure: Number of ACP injections
timeFrame: Up to 61 Months
measure: Dose of ACP injection
timeFrame: Up to 61 Months
measure: Duration of treatment
timeFrame: Up to 61 Months
measure: Annual frequency of ACP injection
timeFrame: Up to 61 Months
measure: Reasons for discontinuation of treatment with ACP
timeFrame: Up to 61 Months
measure: Duration of the treatment interval
timeFrame: Up to 61 Months
measure: Site characteristics
timeFrame: Day 1
measure: Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay
timeFrame: Day 1
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 61 Months
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to 61 Months
measure: Number of participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to 61 Months
measure: Number of participants with Adverse Event of Special Interest (AESI)
timeFrame: Up to 61 Months
measure: Number of Participants maintaining vision
timeFrame: Up to 61 Months
measure: Time to vision loss using various thresholds
timeFrame: Up to 61 Months
measure: Time to thresholds associated with ability to drive
timeFrame: Up to 61 Months
measure: Participant's reading speed
timeFrame: Up to 61 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of AZ
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern CA
state: California
city: Torrance
country: United States
facility: Retina Macula Institute
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic
state: Florida
city: Wesley Chapel
country: United States
facility: Retina Specialists of Tampa
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C.
state: Georgia
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Grand Blanc
country: United States
facility: Retina Associates of Michigan
state: Michigan
city: Madison
country: United States
facility: Mississippi Retina Associates
state: Mississippi
city: Southaven
country: United States
facility: Deep Blue Retina Clinical Research
state: Mississippi
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Toms River
country: United States
facility: NJ Retina
state: New Jersey
city: Brentwood
country: United States
facility: SightMD
state: New York
city: New York
country: United States
facility: Retina Associates of New York
state: New York
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Salt Lake City
country: United States
facility: Salt Lake Retina
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center, Inc.
state: Virginia
city: Warrenton
country: United States
facility: Virginia Retina Center
state: Virginia
city: Greenfield
country: United States
facility: Retina & Vitreous Consultants of Wisconsin
state: Wisconsin
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: