Geographic Atrophy, Macular Degeneration
Conditions
Keywords
Avacincaptad Pegol, IZERVAY™, Treatment patterns, Safety, Functional Outcomes
Brief summary
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.
Interventions
DRUGAvacincaptad pegol (ACP)
intravitreal injection
Sponsors
Astellas Pharma Global Development, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | 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). |
| Annual frequency of ACP injection | 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. |
| Reasons for discontinuation of treatment with ACP | Up to 61 Months | The reasons for discontinuation of treatment with ACP will be recorded. |
| Duration of the treatment interval | 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. |
| Site characteristics | Day 1 | Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban). |
| Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay | Day 1 | Characteristics of interest will be recorded. |
| Number of ACP injections | Up to 61 Months | The number of ACP injections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) | 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. |
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | 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. |
| Number of participants with Adverse Event of Special Interest (AESI) | Up to 61 Months | AESIs are defined as the following AEs: * Endophthalmitis * choroidal neovascularization (CNV) * Intraocular inflammation (including retinal vasculitis) * Increased intraocular pressure (IOP) ≥ 30 mmHg at 30 minutes post injection deemed clinically significant by the investigator * Elevation of IOP post injection requiring surgical/procedural intervention * Ischemic optic neuropathy |
| Number of Participants maintaining vision | Up to 61 Months | Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart. |
| Time to vision loss using various thresholds | 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. |
| Time to thresholds associated with ability to drive | 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. |
| Number of participants with Serious Adverse Events (SAEs) | 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. |
Countries
United States
Contacts
CONTACTAstellas Pharma Global Development, Inc.
STUDY_DIRECTORMedical Director
Astellas Pharma Global Development, Inc.
Outcome results
None listed