Eine Studie, um zu erfahren, wie Avacincaptad Pegol (Izervay™) in der klinischen Praxis bei Menschen mit geografischer Atrophie eingesetzt wird
Eine nicht-interventionelle Beobachtungsstudie zur Bewertung von Behandlungsmustern und Sicherheit von Avacincaptad Pegol (ACP/IZERVAY™) in der klinischen Routinepraxis bei Patienten mit geografischer Atrophie als Folge einer altersbedingten Makuladegeneration
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85053
- Retinal Consultants of AZ
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Scottsdale, Arizona, Vereinigte Staaten, 85255
- Retina Macula Institute of Arizona
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California
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Laguna Hills, California, Vereinigte Staaten, 92653
- Harvard Eye Associates
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Orange, California, Vereinigte Staaten, 92868
- University of California Irvine Medical Center
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Redlands, California, Vereinigte Staaten, 92374
- Retina Consultants of Southern CA
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Sacramento, California, Vereinigte Staaten, 95825
- Retinal Consultants Medical Group Inc
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Torrance, California, Vereinigte Staaten, 90503
- Retina Macula Institute
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Rocky Mountain Lions Eye Institute
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Colorado Springs, Colorado, Vereinigte Staaten, 80909
- Retina Consultants of Southern Colorado
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Lakewood, Colorado, Vereinigte Staaten, 80228
- Colorado Retina Associates, PLLC
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Connecticut
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Greenwich, Connecticut, Vereinigte Staaten, 05830
- Coastal Eye Surgeons
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Florida
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Bonita Springs, Florida, Vereinigte Staaten, 34134
- Advanced Retina Institute
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Coral Gables, Florida, Vereinigte Staaten, 33146
- University of Miami
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Palm Beach Gardens, Florida, Vereinigte Staaten, 33410
- Retina Care Specialists
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Tampa, Florida, Vereinigte Staaten, 33606
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida
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Wesley Chapel, Florida, Vereinigte Staaten, 33544
- Retina Specialists of Tampa
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30909
- Southeast Retina Center, P.C.
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Illinois
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Oak Forest, Illinois, Vereinigte Staaten, 60452
- University Retina and Macula Associates, P.C.
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Oak Park, Illinois, Vereinigte Staaten, 60304
- Illinois Retina Associates
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Peoria, Illinois, Vereinigte Staaten, 61615
- Illinois Eye Center
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Iowa
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West Des Moines, Iowa, Vereinigte Staaten, 50266
- Wolfe Eye Clinic
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Maryland
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Hagerstown, Maryland, Vereinigte Staaten, 21740
- Cumberland Valley Retina Consultants,P.C.
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Michigan
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Grand Blanc, Michigan, Vereinigte Staaten, 48439
- Retina Associates of Michigan
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Minnesota
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Saint Louis Park, Minnesota, Vereinigte Staaten, 55416
- Retina Consultants of Minnesota PLLC
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Mississippi
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Madison, Mississippi, Vereinigte Staaten, 39110
- Mississippi Retina Associates
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Olive Branch, Mississippi, Vereinigte Staaten, 38654
- Brown Family Retina PLLC
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Southaven, Mississippi, Vereinigte Staaten, 38671
- Deep Blue Retina Clinical Research
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Nevada
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Reno, Nevada, Vereinigte Staaten, 89502
- Sierra Eye Associates
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New Jersey
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Dover, New Jersey, Vereinigte Staaten, 07801
- Eye Associates of North Jersey PA
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Edison, New Jersey, Vereinigte Staaten, 08820
- NJ Retina
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Lakewood, New Jersey, Vereinigte Staaten, 08701
- NJ Retina
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Toms River, New Jersey, Vereinigte Staaten, 08755
- NJ Retina
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New York
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Brentwood, New York, Vereinigte Staaten, 11717
- SightMD
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Liverpool, New York, Vereinigte Staaten, 13088
- Retina-Vitreous Surgeons of Central NY
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Massapequa, New York, Vereinigte Staaten, 11758
- NY Retina Ophthalmology PLLC
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New York, New York, Vereinigte Staaten, 10075
- Retina Associates of New York
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Scarsdale, New York, Vereinigte Staaten, 10583
- Long Island Vitreoretinal Consultants
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Shirley, New York, Vereinigte Staaten, 11967
- Vitreoretinal Consultants
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North Carolina
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Wake Forest, North Carolina, Vereinigte Staaten, 27587
- North Carolina Retina Associates
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43221
- The Ohio State University
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Dayton, Ohio, Vereinigte Staaten, 45459
- CEI Physicians PSC, LLC dba
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Oregon
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Eugene, Oregon, Vereinigte Staaten, 97401
- Verum Research, LLC
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Pennsylvania
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Erie, Pennsylvania, Vereinigte Staaten, 16507
- Erie Retina Research
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Tennessee
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Knoxville, Tennessee, Vereinigte Staaten, 37920
- Southeastern Retina Associates, P.C.
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Knoxville, Tennessee, Vereinigte Staaten, 37923
- Southeastern Retina Associates, P.C.
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Memphis, Tennessee, Vereinigte Staaten, 38119
- Mid South Retina Associates
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, Vereinigte Staaten, 79606
- Retina Research Institute of Texas
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Dallas, Texas, Vereinigte Staaten, 75243
- Retina of North Texas
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McAllen, Texas, Vereinigte Staaten, 78503
- Valley Retina Institute
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San Antonio, Texas, Vereinigte Staaten, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, Vereinigte Staaten, 78240
- Retina Associates Of South Texas, Pa
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Utah
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Murray, Utah, Vereinigte Staaten, 84107
- Retina Associates of Utah, P.C.
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Salt Lake City, Utah, Vereinigte Staaten, 84120
- Salt Lake Retina
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Virginia
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Fairfax, Virginia, Vereinigte Staaten, 22031
- The Retina Group of Washington
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Lynchburg, Virginia, Vereinigte Staaten, 24502
- Piedmont Eye Center, Inc.
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Warrenton, Virginia, Vereinigte Staaten, 20186
- Virginia Retina Center
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Wisconsin
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Milwaukee, Wisconsin, Vereinigte Staaten, 53226
- Retina & Vitreous Consultants of Wisconsin
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
intravitreal injection
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of ACP injections
Zeitfenster: Up to 61 Months
|
The number of ACP injections. |
Up to 61 Months
|
|
Duration of treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 61 Months
|
The reasons for discontinuation of treatment with ACP will be recorded. |
Up to 61 Months
|
|
Duration of the treatment interval
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1
|
Characteristics of interest will be recorded. |
Day 1
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of participants with Adverse Events (AEs)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to 61 Months
|
AESIs are defined as the following AEs:
|
Up to 61 Months
|
|
Number of Participants maintaining vision
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Medical Director, Astellas Pharma Global Development, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 3021-MA-3543
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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/.
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .