Une étude pour savoir comment l'Avacincaptad Pegol (Izervay™) est utilisé en pratique clinique chez les personnes souffrant d'atrophie géographique
Une étude observationnelle non interventionnelle pour évaluer les modèles de traitement et l'innocuité de l'Avacincaptad Pegol (ACP/IZERVAY™) dans la pratique clinique de routine chez les patients présentant une atrophie géographique secondaire à une dégénérescence maculaire liée à l'âge
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis, 85053
- Retinal Consultants of AZ
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Scottsdale, Arizona, États-Unis, 85255
- Retina Macula Institute of Arizona
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California
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Laguna Hills, California, États-Unis, 92653
- Harvard Eye Associates
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Orange, California, États-Unis, 92868
- University of California Irvine Medical Center
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Redlands, California, États-Unis, 92374
- Retina Consultants of Southern CA
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Sacramento, California, États-Unis, 95825
- Retinal Consultants Medical Group Inc
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Torrance, California, États-Unis, 90503
- Retina Macula Institute
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Rocky Mountain Lions Eye Institute
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Colorado Springs, Colorado, États-Unis, 80909
- Retina Consultants of Southern Colorado
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Lakewood, Colorado, États-Unis, 80228
- Colorado Retina Associates, PLLC
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Connecticut
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Greenwich, Connecticut, États-Unis, 05830
- Coastal Eye Surgeons
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Florida
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Bonita Springs, Florida, États-Unis, 34134
- Advanced Retina Institute
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Coral Gables, Florida, États-Unis, 33146
- University of Miami
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Palm Beach Gardens, Florida, États-Unis, 33410
- Retina Care Specialists
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Tampa, Florida, États-Unis, 33606
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida
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Wesley Chapel, Florida, États-Unis, 33544
- Retina Specialists of Tampa
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Georgia
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Augusta, Georgia, États-Unis, 30909
- Southeast Retina Center, P.C.
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Illinois
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Oak Forest, Illinois, États-Unis, 60452
- University Retina and Macula Associates, P.C.
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Oak Park, Illinois, États-Unis, 60304
- Illinois Retina Associates
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Peoria, Illinois, États-Unis, 61615
- Illinois Eye Center
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Iowa
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West Des Moines, Iowa, États-Unis, 50266
- Wolfe Eye Clinic
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Maryland
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Hagerstown, Maryland, États-Unis, 21740
- Cumberland Valley Retina Consultants,P.C.
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Michigan
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Grand Blanc, Michigan, États-Unis, 48439
- Retina Associates of Michigan
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Minnesota
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Saint Louis Park, Minnesota, États-Unis, 55416
- Retina Consultants of Minnesota PLLC
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Mississippi
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Madison, Mississippi, États-Unis, 39110
- Mississippi Retina Associates
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Olive Branch, Mississippi, États-Unis, 38654
- Brown Family Retina PLLC
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Southaven, Mississippi, États-Unis, 38671
- Deep Blue Retina Clinical Research
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Nevada
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Reno, Nevada, États-Unis, 89502
- Sierra Eye Associates
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New Jersey
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Dover, New Jersey, États-Unis, 07801
- Eye Associates of North Jersey PA
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Edison, New Jersey, États-Unis, 08820
- NJ Retina
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Lakewood, New Jersey, États-Unis, 08701
- NJ Retina
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Toms River, New Jersey, États-Unis, 08755
- NJ Retina
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New York
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Brentwood, New York, États-Unis, 11717
- SightMD
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Liverpool, New York, États-Unis, 13088
- Retina-Vitreous Surgeons of Central NY
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Massapequa, New York, États-Unis, 11758
- NY Retina Ophthalmology PLLC
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New York, New York, États-Unis, 10075
- Retina Associates of New York
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Scarsdale, New York, États-Unis, 10583
- Long Island Vitreoretinal Consultants
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Shirley, New York, États-Unis, 11967
- Vitreoretinal Consultants
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North Carolina
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Wake Forest, North Carolina, États-Unis, 27587
- North Carolina Retina Associates
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Ohio
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Columbus, Ohio, États-Unis, 43221
- The Ohio State University
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Dayton, Ohio, États-Unis, 45459
- CEI Physicians PSC, LLC dba
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Oregon
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Eugene, Oregon, États-Unis, 97401
- Verum Research, LLC
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Pennsylvania
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Erie, Pennsylvania, États-Unis, 16507
- Erie Retina Research
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Tennessee
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Knoxville, Tennessee, États-Unis, 37920
- Southeastern Retina Associates, P.C.
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Knoxville, Tennessee, États-Unis, 37923
- Southeastern Retina Associates, P.C.
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Memphis, Tennessee, États-Unis, 38119
- Mid South Retina Associates
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Nashville, Tennessee, États-Unis, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, États-Unis, 79606
- Retina Research Institute of Texas
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Dallas, Texas, États-Unis, 75243
- Retina of North Texas
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McAllen, Texas, États-Unis, 78503
- Valley Retina Institute
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San Antonio, Texas, États-Unis, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, États-Unis, 78240
- Retina Associates Of South Texas, Pa
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Utah
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Murray, Utah, États-Unis, 84107
- Retina Associates of Utah, P.C.
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Salt Lake City, Utah, États-Unis, 84120
- Salt Lake Retina
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Virginia
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Fairfax, Virginia, États-Unis, 22031
- The Retina Group of Washington
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Lynchburg, Virginia, États-Unis, 24502
- Piedmont Eye Center, Inc.
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Warrenton, Virginia, États-Unis, 20186
- Virginia Retina Center
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Retina & Vitreous Consultants of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
intravitreal injection
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of ACP injections
Délai: Up to 61 Months
|
The number of ACP injections. |
Up to 61 Months
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Duration of treatment
Délai: 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
Délai: 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
Délai: Up to 61 Months
|
The reasons for discontinuation of treatment with ACP will be recorded. |
Up to 61 Months
|
|
Duration of the treatment interval
Délai: 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
Délai: Day 1
|
Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban). |
Day 1
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Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay
Délai: Day 1
|
Characteristics of interest will be recorded. |
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants with Adverse Events (AEs)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Up to 61 Months
|
AESIs are defined as the following AEs:
|
Up to 61 Months
|
|
Number of Participants maintaining vision
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Astellas Pharma Global Development, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 3021-MA-3543
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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/.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .