Uno studio per scoprire come Avacincaptad Pegol (Izervay™) viene utilizzato nella pratica clinica in persone affette da atrofia geografica
Uno studio osservazionale non interventistico per valutare i modelli di trattamento e la sicurezza di Avacincaptad Pegol (ACP/IZERVAY™) nella pratica clinica di routine in pazienti con atrofia geografica secondaria a degenerazione maculare legata all'età
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Arizona
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Phoenix, Arizona, Stati Uniti, 85053
- Retinal Consultants of AZ
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Scottsdale, Arizona, Stati Uniti, 85255
- Retina Macula Institute of Arizona
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California
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Laguna Hills, California, Stati Uniti, 92653
- Harvard Eye Associates
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Orange, California, Stati Uniti, 92868
- University of California Irvine Medical Center
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Redlands, California, Stati Uniti, 92374
- Retina Consultants of Southern CA
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Sacramento, California, Stati Uniti, 95825
- Retinal Consultants Medical Group Inc
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Torrance, California, Stati Uniti, 90503
- Retina Macula Institute
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- Rocky Mountain Lions Eye Institute
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Colorado Springs, Colorado, Stati Uniti, 80909
- Retina Consultants of Southern Colorado
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Lakewood, Colorado, Stati Uniti, 80228
- Colorado Retina Associates, PLLC
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Connecticut
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Greenwich, Connecticut, Stati Uniti, 05830
- Coastal Eye Surgeons
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Florida
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Bonita Springs, Florida, Stati Uniti, 34134
- Advanced Retina Institute
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Coral Gables, Florida, Stati Uniti, 33146
- University of Miami
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Palm Beach Gardens, Florida, Stati Uniti, 33410
- Retina Care Specialists
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Tampa, Florida, Stati Uniti, 33606
- Eye Physicians of Pinellas PA dba Eye Institute of West Florida
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Wesley Chapel, Florida, Stati Uniti, 33544
- Retina Specialists of Tampa
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Georgia
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Augusta, Georgia, Stati Uniti, 30909
- Southeast Retina Center, P.C.
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Illinois
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Oak Forest, Illinois, Stati Uniti, 60452
- University Retina and Macula Associates, P.C.
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Oak Park, Illinois, Stati Uniti, 60304
- Illinois Retina Associates
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Peoria, Illinois, Stati Uniti, 61615
- Illinois Eye Center
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Iowa
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West Des Moines, Iowa, Stati Uniti, 50266
- Wolfe Eye Clinic
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Maryland
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Hagerstown, Maryland, Stati Uniti, 21740
- Cumberland Valley Retina Consultants,P.C.
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Michigan
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Grand Blanc, Michigan, Stati Uniti, 48439
- Retina Associates of Michigan
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Minnesota
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Saint Louis Park, Minnesota, Stati Uniti, 55416
- Retina Consultants of Minnesota PLLC
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Mississippi
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Madison, Mississippi, Stati Uniti, 39110
- Mississippi Retina Associates
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Olive Branch, Mississippi, Stati Uniti, 38654
- Brown Family Retina PLLC
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Southaven, Mississippi, Stati Uniti, 38671
- Deep Blue Retina Clinical Research
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Nevada
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Reno, Nevada, Stati Uniti, 89502
- Sierra Eye Associates
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New Jersey
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Dover, New Jersey, Stati Uniti, 07801
- Eye Associates of North Jersey PA
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Edison, New Jersey, Stati Uniti, 08820
- NJ Retina
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Lakewood, New Jersey, Stati Uniti, 08701
- NJ Retina
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Toms River, New Jersey, Stati Uniti, 08755
- NJ Retina
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New York
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Brentwood, New York, Stati Uniti, 11717
- SightMD
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Liverpool, New York, Stati Uniti, 13088
- Retina-Vitreous Surgeons of Central NY
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Massapequa, New York, Stati Uniti, 11758
- NY Retina Ophthalmology PLLC
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New York, New York, Stati Uniti, 10075
- Retina Associates of New York
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Scarsdale, New York, Stati Uniti, 10583
- Long Island Vitreoretinal Consultants
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Shirley, New York, Stati Uniti, 11967
- Vitreoretinal Consultants
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North Carolina
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Wake Forest, North Carolina, Stati Uniti, 27587
- North Carolina Retina Associates
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Ohio
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Columbus, Ohio, Stati Uniti, 43221
- The Ohio State University
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Dayton, Ohio, Stati Uniti, 45459
- CEI Physicians PSC, LLC dba
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Oregon
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Eugene, Oregon, Stati Uniti, 97401
- Verum Research, LLC
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Pennsylvania
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Erie, Pennsylvania, Stati Uniti, 16507
- Erie Retina Research
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37920
- Southeastern Retina Associates, P.C.
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Knoxville, Tennessee, Stati Uniti, 37923
- Southeastern Retina Associates, P.C.
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Memphis, Tennessee, Stati Uniti, 38119
- Mid South Retina Associates
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Nashville, Tennessee, Stati Uniti, 37203
- Tennessee Retina, PC
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Texas
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Abilene, Texas, Stati Uniti, 79606
- Retina Research Institute of Texas
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Dallas, Texas, Stati Uniti, 75243
- Retina of North Texas
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McAllen, Texas, Stati Uniti, 78503
- Valley Retina Institute
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San Antonio, Texas, Stati Uniti, 78240
- Medical Center Ophthalmology Associates
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San Antonio, Texas, Stati Uniti, 78240
- Retina Associates Of South Texas, Pa
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Utah
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Murray, Utah, Stati Uniti, 84107
- Retina Associates of Utah, P.C.
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Salt Lake City, Utah, Stati Uniti, 84120
- Salt Lake Retina
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Virginia
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Fairfax, Virginia, Stati Uniti, 22031
- The Retina Group of Washington
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Lynchburg, Virginia, Stati Uniti, 24502
- Piedmont Eye Center, Inc.
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Warrenton, Virginia, Stati Uniti, 20186
- Virginia Retina Center
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Retina & Vitreous Consultants of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Izervay
Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
intravitreal injection
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of ACP injections
Lasso di tempo: Up to 61 Months
|
The number of ACP injections. |
Up to 61 Months
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Duration of treatment
Lasso di tempo: Up to 61 Months
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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
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Annual frequency of ACP injection
Lasso di tempo: Up to 61 Months
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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
|
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Reasons for discontinuation of treatment with ACP
Lasso di tempo: Up to 61 Months
|
The reasons for discontinuation of treatment with ACP will be recorded. |
Up to 61 Months
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Duration of the treatment interval
Lasso di tempo: 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
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Site characteristics
Lasso di tempo: 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
Lasso di tempo: Day 1
|
Characteristics of interest will be recorded. |
Day 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants with Adverse Events (AEs)
Lasso di tempo: 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
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Number of participants with Serious Adverse Events (SAEs)
Lasso di tempo: Up to 61 Months
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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
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Number of participants with Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: 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
|
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Number of participants with Adverse Event of Special Interest (AESI)
Lasso di tempo: Up to 61 Months
|
AESIs are defined as the following AEs:
|
Up to 61 Months
|
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Number of Participants maintaining vision
Lasso di tempo: Up to 61 Months
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Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
Up to 61 Months
|
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Time to vision loss using various thresholds
Lasso di tempo: 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
|
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Time to thresholds associated with ability to drive
Lasso di tempo: Up to 61 Months
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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
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Medical Director, Astellas Pharma Global Development, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 3021-MA-3543
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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/.
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .