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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Izervay | Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacincaptad pegol (ACP) | Drug | intravitreal injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ACP injections | The number of ACP injections. | Up to 61 Months |
| Duration of treatment | 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 | 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 | The reasons for discontinuation of treatment with ACP will be recorded. | Up to 61 Months |
| Duration of the treatment interval | 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 | 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 | Characteristics of interest will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have any contraindication or are not eligible for treatment with ACP, including the following:
Patients currently participating in an investigational program with interventions outside of routine clinical practice.
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.
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.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Astellas Pharma Global Development, Inc. | Contact | 800-555-5555 | Astellas.registration@astellas.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Retina Clinical Trials, LLC | Withdrawn | Phoenix | Arizona | 85050 | United States | |
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/.
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| Day 1 |
| Up to 61 Months |
| Number of participants with Serious Adverse Events (SAEs) | 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) | 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) | AESIs are defined as the following AEs:
| Up to 61 Months |
| Number of Participants maintaining vision | 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 | 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 | 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 |
| Retinal Consultants of AZ |
| Recruiting |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Retina Macula Institute of Arizona | Recruiting | Scottsdale | Arizona | 85255 | United States |
| The Retina Partners | Withdrawn | Encino | California | 91436 | United States |
| Harvard Eye Associates | Recruiting | Laguna Hills | California | 92653 | United States |
| University of California Irvine Medical Center | Recruiting | Orange | California | 92868 | United States |
| Retina Consultants of Southern CA | Recruiting | Redlands | California | 92374 | United States |
| Retinal Consultants Medical Group Inc | Recruiting | Sacramento | California | 95825 | United States |
| Retina Macula Institute | Recruiting | Torrance | California | 90503 | United States |
| Rocky Mountain Lions Eye Institute | Recruiting | Aurora | Colorado | 80045 | United States |
| Retina Consultants of Southern Colorado | Recruiting | Colorado Springs | Colorado | 80909 | United States |
| Colorado Retina Associates, PLLC | Recruiting | Lakewood | Colorado | 80228 | United States |
| Coastal Eye Surgeons | Recruiting | Greenwich | Connecticut | 05830 | United States |
| Florida Eye Clinic | Withdrawn | Altamonte Springs | Florida | 32701 | United States |
| Advanced Retina Institute | Recruiting | Bonita Springs | Florida | 34134 | United States |
| University of Miami | Recruiting | Coral Gables | Florida | 33146 | United States |
| Retina Care Specialists | Recruiting | Palm Beach Gardens | Florida | 33410 | United States |
| Eye Physicians of Pinellas PA dba Eye Institute of West Florida | Recruiting | Tampa | Florida | 33606 | United States |
| Retina Specialists of Tampa | Recruiting | Wesley Chapel | Florida | 33544 | United States |
| Southeast Retina Center, P.C. | Recruiting | Augusta | Georgia | 30909 | United States |
| University Retina and Macula Associates, P.C. | Recruiting | Oak Forest | Illinois | 60452 | United States |
| Illinois Retina Associates | Recruiting | Oak Park | Illinois | 60304 | United States |
| Illinois Eye Center | Recruiting | Peoria | Illinois | 61615 | United States |
| Wolfe Eye Clinic | Recruiting | West Des Moines | Iowa | 50266 | United States |
| Cumberland Valley Retina Consultants,P.C. | Recruiting | Hagerstown | Maryland | 21740 | United States |
| Retina Specialists | Withdrawn | Towson | Maryland | 21204 | United States |
| Retina Associates of Michigan | Recruiting | Grand Blanc | Michigan | 48439 | United States |
| Retina Consultants of Minnesota PLLC | Recruiting | Saint Louis Park | Minnesota | 55416 | United States |
| Mississippi Retina Associates | Recruiting | Madison | Mississippi | 39110 | United States |
| Brown Family Retina PLLC | Recruiting | Olive Branch | Mississippi | 38654 | United States |
| Deep Blue Retina Clinical Research | Recruiting | Southaven | Mississippi | 38671 | United States |
| Sierra Eye Associates | Active, not recruiting | Reno | Nevada | 89502 | United States |
| Eye Associates of North Jersey PA | Recruiting | Dover | New Jersey | 07801 | United States |
| NJ Retina | Recruiting | Edison | New Jersey | 08820 | United States |
| NJ Retina | Recruiting | Lakewood | New Jersey | 08701 | United States |
| Monmouth Retina Consultants | Withdrawn | Little Silver | New Jersey | 07739 | United States |
| NJ Retina | Recruiting | Toms River | New Jersey | 08755 | United States |
| SightMD | Recruiting | Brentwood | New York | 11717 | United States |
| Retina-Vitreous Surgeons of Central NY | Recruiting | Liverpool | New York | 13088 | United States |
| NY Retina Ophthalmology PLLC | Active, not recruiting | Massapequa | New York | 11758 | United States |
| Retina Associates of New York | Active, not recruiting | New York | New York | 10075 | United States |
| Long Island Vitreoretinal Consultants | Recruiting | Scarsdale | New York | 10583 | United States |
| Vitreoretinal Consultants | Recruiting | Shirley | New York | 11967 | United States |
| North Carolina Retina Associates | Withdrawn | Cary | North Carolina | 27511 | United States |
| North Carolina Retina Associates | Recruiting | Wake Forest | North Carolina | 27587 | United States |
| The Ohio State University | Recruiting | Columbus | Ohio | 43221 | United States |
| CEI Physicians PSC, LLC dba | Recruiting | Dayton | Ohio | 45459 | United States |
| Verum Research, LLC | Recruiting | Eugene | Oregon | 97401 | United States |
| Erie Retina Research | Recruiting | Erie | Pennsylvania | 16507 | United States |
| Southeastern Retina Associates, P.C. | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Southeastern Retina Associates, P.C. | Recruiting | Knoxville | Tennessee | 37923 | United States |
| Mid South Retina Associates | Recruiting | Memphis | Tennessee | 38119 | United States |
| Tennessee Retina, PC | Recruiting | Nashville | Tennessee | 37203 | United States |
| Retina Research Institute of Texas | Recruiting | Abilene | Texas | 79606 | United States |
| Retina & Vitreous of Texas | Withdrawn | Bellaire | Texas | 77401 | United States |
| Retina of North Texas | Recruiting | Dallas | Texas | 75243 | United States |
| Valley Retina Institute | Recruiting | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | Recruiting | San Antonio | Texas | 78240 | United States |
| Retina Associates Of South Texas, Pa | Recruiting | San Antonio | Texas | 78240 | United States |
| Retina Associates of Utah, P.C. | Recruiting | Murray | Utah | 84107 | United States |
| Salt Lake Retina | Recruiting | Salt Lake City | Utah | 84120 | United States |
| The Retina Group of Washington | Recruiting | Fairfax | Virginia | 22031 | United States |
| Piedmont Eye Center, Inc. | Recruiting | Lynchburg | Virginia | 24502 | United States |
| Virginia Retina Center | Recruiting | Warrenton | Virginia | 20186 | United States |
| Retina & Vitreous Consultants of Wisconsin | Active, not recruiting | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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