Een onderzoek om te leren hoe Avacincaptad Pegol (Izervay™) in de klinische praktijk wordt gebruikt bij mensen met geografische atrofie
Een niet-interventioneel, observationeel onderzoek om behandelingspatronen en veiligheid van Avacincaptad Pegol (ACP/IZERVAY™) te evalueren in de routinematige klinische praktijk bij patiënten met geografische atrofie secundair aan leeftijdsgebonden maculaire degeneratie
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Arizona
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Phoenix, Arizona, Verenigde Staten, 85053
- Retinal Consultants of AZ
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Scottsdale, Arizona, Verenigde Staten, 85255
- Retina Macula Institute of Arizona
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California
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Laguna Hills, California, Verenigde Staten, 92653
- Harvard Eye Associates
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Orange, California, Verenigde Staten, 92868
- University of California Irvine Medical Center
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Redlands, California, Verenigde Staten, 92374
- Retina Consultants of Southern CA
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Sacramento, California, Verenigde Staten, 95825
- Retinal Consultants Medical Group Inc
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Torrance, California, Verenigde Staten, 90503
- Retina Macula Institute
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Rocky Mountain Lions Eye Institute
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Colorado Springs, Colorado, Verenigde Staten, 80909
- Retina Consultants of Southern Colorado
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Lakewood, Colorado, Verenigde Staten, 80228
- Colorado Retina Associates, PLLC
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Connecticut
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Greenwich, Connecticut, Verenigde Staten, 05830
- Coastal Eye Surgeons
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Florida
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Bonita Springs, Florida, Verenigde Staten, 34134
- Advanced Retina Institute
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Coral Gables, Florida, Verenigde Staten, 33146
- University of Miami
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Palm Beach Gardens, Florida, Verenigde Staten, 33410
- Retina Care Specialists
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Tampa, Florida, Verenigde Staten, 33606
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida
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Wesley Chapel, Florida, Verenigde Staten, 33544
- Retina Specialists of Tampa
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Georgia
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Augusta, Georgia, Verenigde Staten, 30909
- Southeast Retina Center, P.C.
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Illinois
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Oak Forest, Illinois, Verenigde Staten, 60452
- University Retina and Macula Associates, P.C.
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Oak Park, Illinois, Verenigde Staten, 60304
- Illinois Retina Associates
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Peoria, Illinois, Verenigde Staten, 61615
- Illinois Eye Center
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Iowa
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West Des Moines, Iowa, Verenigde Staten, 50266
- Wolfe Eye Clinic
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Maryland
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Hagerstown, Maryland, Verenigde Staten, 21740
- Cumberland Valley Retina Consultants,P.C.
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Michigan
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Grand Blanc, Michigan, Verenigde Staten, 48439
- Retina Associates of Michigan
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Minnesota
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Retina Consultants of Minnesota PLLC
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Mississippi
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Madison, Mississippi, Verenigde Staten, 39110
- Mississippi Retina Associates
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Olive Branch, Mississippi, Verenigde Staten, 38654
- Brown Family Retina PLLC
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Southaven, Mississippi, Verenigde Staten, 38671
- Deep Blue Retina Clinical Research
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Nevada
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Reno, Nevada, Verenigde Staten, 89502
- Sierra Eye Associates
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New Jersey
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Dover, New Jersey, Verenigde Staten, 07801
- Eye Associates of North Jersey PA
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Edison, New Jersey, Verenigde Staten, 08820
- NJ Retina
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Lakewood, New Jersey, Verenigde Staten, 08701
- NJ Retina
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Toms River, New Jersey, Verenigde Staten, 08755
- NJ Retina
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New York
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Brentwood, New York, Verenigde Staten, 11717
- SightMD
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Liverpool, New York, Verenigde Staten, 13088
- Retina-Vitreous Surgeons of Central NY
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Massapequa, New York, Verenigde Staten, 11758
- NY Retina Ophthalmology PLLC
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New York, New York, Verenigde Staten, 10075
- Retina Associates of New York
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Scarsdale, New York, Verenigde Staten, 10583
- Long Island Vitreoretinal Consultants
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Shirley, New York, Verenigde Staten, 11967
- Vitreoretinal Consultants
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North Carolina
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Wake Forest, North Carolina, Verenigde Staten, 27587
- North Carolina Retina Associates
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Ohio
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Columbus, Ohio, Verenigde Staten, 43221
- The Ohio State University
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Dayton, Ohio, Verenigde Staten, 45459
- CEI Physicians PSC, LLC dba
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Oregon
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Eugene, Oregon, Verenigde Staten, 97401
- Verum Research, LLC
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Pennsylvania
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Erie, Pennsylvania, Verenigde Staten, 16507
- Erie Retina Research
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37920
- Southeastern Retina Associates, P.C.
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Knoxville, Tennessee, Verenigde Staten, 37923
- Southeastern Retina Associates, P.C.
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Memphis, Tennessee, Verenigde Staten, 38119
- Mid South Retina Associates
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Nashville, Tennessee, Verenigde Staten, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, Verenigde Staten, 79606
- Retina Research Institute of Texas
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Dallas, Texas, Verenigde Staten, 75243
- Retina of North Texas
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McAllen, Texas, Verenigde Staten, 78503
- Valley Retina Institute
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San Antonio, Texas, Verenigde Staten, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, Verenigde Staten, 78240
- Retina Associates Of South Texas, Pa
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Utah
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Murray, Utah, Verenigde Staten, 84107
- Retina Associates of Utah, P.C.
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Salt Lake City, Utah, Verenigde Staten, 84120
- Salt Lake Retina
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Virginia
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Fairfax, Virginia, Verenigde Staten, 22031
- The Retina Group of Washington
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Lynchburg, Virginia, Verenigde Staten, 24502
- Piedmont Eye Center, Inc.
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Warrenton, Virginia, Verenigde Staten, 20186
- Virginia Retina Center
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Retina & Vitreous Consultants of Wisconsin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
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:
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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
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Patients currently participating in an investigational program with interventions outside of routine clinical practice.
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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.
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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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
intravitreal injection
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of ACP injections
Tijdsspanne: Up to 61 Months
|
The number of ACP injections. |
Up to 61 Months
|
|
Duration of treatment
Tijdsspanne: 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). |
Up to 61 Months
|
|
Annual frequency of ACP injection
Tijdsspanne: 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. |
Up to 61 Months
|
|
Reasons for discontinuation of treatment with ACP
Tijdsspanne: Up to 61 Months
|
The reasons for discontinuation of treatment with ACP will be recorded. |
Up to 61 Months
|
|
Duration of the treatment interval
Tijdsspanne: 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. |
Up to 61 Months
|
|
Site characteristics
Tijdsspanne: Day 1
|
Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban). |
Day 1
|
|
Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay
Tijdsspanne: Day 1
|
Characteristics of interest will be recorded. |
Day 1
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with Adverse Events (AEs)
Tijdsspanne: Up to 61 Months
|
An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product. |
Up to 61 Months
|
|
Number of participants with Serious Adverse Events (SAEs)
Tijdsspanne: Up to 61 Months
|
An SAE is defined as an AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or other medically important events. |
Up to 61 Months
|
|
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to 61 Months
|
TEAE is defined an AE observed after starting administration of the study drug and will continue until 30 days after the last administration or until last study visit, whichever is sooner. |
Up to 61 Months
|
|
Number of participants with Adverse Event of Special Interest (AESI)
Tijdsspanne: Up to 61 Months
|
AESIs are defined as the following AEs:
|
Up to 61 Months
|
|
Number of Participants maintaining vision
Tijdsspanne: Up to 61 Months
|
Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
Up to 61 Months
|
|
Time to vision loss using various thresholds
Tijdsspanne: Up to 61 Months
|
Time to vision loss is defined as the difference between the date when vision loss was reported for the first time and the start date of treatment. |
Up to 61 Months
|
|
Time to thresholds associated with ability to drive
Tijdsspanne: Up to 61 Months
|
Time to thresholds associated with the ability to drive will be based on visual acuity data captured as per standard of care. |
Up to 61 Months
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Medical Director, Astellas Pharma Global Development, Inc.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 3021-MA-3543
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .