Исследование, посвященное изучению того, как Авацинкаптад Пегол (Изервай™) используется в клинической практике у людей с географической атрофией
Неинтервенционное обсервационное исследование для оценки схемы лечения и безопасности авацинкаптада пегола (ACP/IZERVAY™) в рутинной клинической практике у пациентов с географической атрофией, вторичной по отношению к возрастной макулярной дегенерации
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85053
- Retinal Consultants of AZ
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Scottsdale, Arizona, Соединенные Штаты, 85255
- Retina Macula Institute of Arizona
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California
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Laguna Hills, California, Соединенные Штаты, 92653
- Harvard Eye Associates
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Orange, California, Соединенные Штаты, 92868
- University of California Irvine Medical Center
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Redlands, California, Соединенные Штаты, 92374
- Retina Consultants of Southern CA
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Sacramento, California, Соединенные Штаты, 95825
- Retinal Consultants Medical Group Inc
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Torrance, California, Соединенные Штаты, 90503
- Retina Macula Institute
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Colorado
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Aurora, Colorado, Соединенные Штаты, 80045
- Rocky Mountain Lions Eye Institute
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Colorado Springs, Colorado, Соединенные Штаты, 80909
- Retina Consultants of Southern Colorado
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Lakewood, Colorado, Соединенные Штаты, 80228
- Colorado Retina Associates, PLLC
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Connecticut
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Greenwich, Connecticut, Соединенные Штаты, 05830
- Coastal Eye Surgeons
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Florida
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Bonita Springs, Florida, Соединенные Штаты, 34134
- Advanced Retina Institute
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Coral Gables, Florida, Соединенные Штаты, 33146
- University of Miami
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Palm Beach Gardens, Florida, Соединенные Штаты, 33410
- Retina Care Specialists
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Tampa, Florida, Соединенные Штаты, 33606
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida
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Wesley Chapel, Florida, Соединенные Штаты, 33544
- Retina Specialists of Tampa
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Georgia
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Augusta, Georgia, Соединенные Штаты, 30909
- Southeast Retina Center, P.C.
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Illinois
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Oak Forest, Illinois, Соединенные Штаты, 60452
- University Retina and Macula Associates, P.C.
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Oak Park, Illinois, Соединенные Штаты, 60304
- Illinois Retina Associates
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Peoria, Illinois, Соединенные Штаты, 61615
- Illinois Eye Center
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Iowa
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West Des Moines, Iowa, Соединенные Штаты, 50266
- Wolfe Eye Clinic
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Maryland
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Hagerstown, Maryland, Соединенные Штаты, 21740
- Cumberland Valley Retina Consultants,P.C.
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Michigan
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Grand Blanc, Michigan, Соединенные Штаты, 48439
- Retina Associates of Michigan
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Minnesota
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Saint Louis Park, Minnesota, Соединенные Штаты, 55416
- Retina Consultants of Minnesota PLLC
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Mississippi
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Madison, Mississippi, Соединенные Штаты, 39110
- Mississippi Retina Associates
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Olive Branch, Mississippi, Соединенные Штаты, 38654
- Brown Family Retina PLLC
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Southaven, Mississippi, Соединенные Штаты, 38671
- Deep Blue Retina Clinical Research
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Nevada
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Reno, Nevada, Соединенные Штаты, 89502
- Sierra Eye Associates
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New Jersey
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Dover, New Jersey, Соединенные Штаты, 07801
- Eye Associates of North Jersey PA
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Edison, New Jersey, Соединенные Штаты, 08820
- NJ Retina
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Lakewood, New Jersey, Соединенные Штаты, 08701
- NJ Retina
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Toms River, New Jersey, Соединенные Штаты, 08755
- NJ Retina
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New York
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Brentwood, New York, Соединенные Штаты, 11717
- SightMD
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Liverpool, New York, Соединенные Штаты, 13088
- Retina-Vitreous Surgeons of Central NY
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Massapequa, New York, Соединенные Штаты, 11758
- NY Retina Ophthalmology PLLC
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New York, New York, Соединенные Штаты, 10075
- Retina Associates of New York
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Scarsdale, New York, Соединенные Штаты, 10583
- Long Island Vitreoretinal Consultants
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Shirley, New York, Соединенные Штаты, 11967
- Vitreoretinal Consultants
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North Carolina
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Wake Forest, North Carolina, Соединенные Штаты, 27587
- North Carolina Retina Associates
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43221
- The Ohio State University
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Dayton, Ohio, Соединенные Штаты, 45459
- CEI Physicians PSC, LLC dba
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Oregon
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Eugene, Oregon, Соединенные Штаты, 97401
- Verum Research, LLC
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Pennsylvania
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Erie, Pennsylvania, Соединенные Штаты, 16507
- Erie Retina Research
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Tennessee
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Knoxville, Tennessee, Соединенные Штаты, 37920
- Southeastern Retina Associates, P.C.
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Knoxville, Tennessee, Соединенные Штаты, 37923
- Southeastern Retina Associates, P.C.
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Memphis, Tennessee, Соединенные Штаты, 38119
- Mid South Retina Associates
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Nashville, Tennessee, Соединенные Штаты, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, Соединенные Штаты, 79606
- Retina Research Institute of Texas
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Dallas, Texas, Соединенные Штаты, 75243
- Retina of North Texas
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McAllen, Texas, Соединенные Штаты, 78503
- Valley Retina Institute
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San Antonio, Texas, Соединенные Штаты, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, Соединенные Штаты, 78240
- Retina Associates Of South Texas, Pa
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Utah
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Murray, Utah, Соединенные Штаты, 84107
- Retina Associates of Utah, P.C.
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Salt Lake City, Utah, Соединенные Штаты, 84120
- Salt Lake Retina
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- The Retina Group of Washington
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Lynchburg, Virginia, Соединенные Штаты, 24502
- Piedmont Eye Center, Inc.
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Warrenton, Virginia, Соединенные Штаты, 20186
- Virginia Retina Center
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Wisconsin
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Milwaukee, Wisconsin, Соединенные Штаты, 53226
- Retina & Vitreous Consultants of Wisconsin
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
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.
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
intravitreal injection
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of ACP injections
Временное ограничение: Up to 61 Months
|
The number of ACP injections. |
Up to 61 Months
|
|
Duration of treatment
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Up to 61 Months
|
The reasons for discontinuation of treatment with ACP will be recorded. |
Up to 61 Months
|
|
Duration of the treatment interval
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Day 1
|
Characteristics of interest will be recorded. |
Day 1
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of participants with Adverse Events (AEs)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Up to 61 Months
|
AESIs are defined as the following AEs:
|
Up to 61 Months
|
|
Number of Participants maintaining vision
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Директор по исследованиям: Medical Director, Astellas Pharma Global Development, Inc.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 3021-MA-3543
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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/.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .