Geographic Atrophy, Age-Related Macular Degeneration
Conditions
Keywords
avacincaptad pegol, IZERVAY, ASP3021
Brief summary
Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both. This study is for people in Japan of 40 years of age or older, who have geographic atrophy. The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021. During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection. People will be in the study for about 1 year. People will visit their study clinic several times for health checks.
Detailed description
IZERVAY has received marketing approval in Japan. The study will continue as a post marketing study in Japan.
Interventions
intravitreal injection
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has non-foveal central point involvement geographic atrophy (GA) secondary to age-related macular degeneration (AMD). * Participant has total GA area ≥ 2.0 and ≤ 17.5 mm\^2 (1 and 7 disc areas \[DA\] respectively), determined by fundus autofluorescence (FAF) screening images. * If participant has multifocal GA, at least one focal lesion should measure ≥ 1.25 mm\^2 (0.5 DA). * Participant has GA in part within 1500 microns from the fovea center point. * Participant has GA that must be able to be photographed in its entirety. * Participant has best corrected visual acuity (BCVA) between 20/25 and 20/320, inclusive. * Participant has clear ocular media and adequate pupillary dilatation in both eyes to allow for all imaging procedures, including good quality stereoscopic fundus photography and FAF. * Participant has intraocular pressure (IOP) of ≤ 21 mmHg or less. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a women of childbearing potential (WOCBP). * WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 40 days after final study intervention administration. * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 40 days after final study intervention administration. * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 40 days after final study intervention administration. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 40 days after final study intervention administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 40 days after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 40 days after final study intervention administration. * Participant has ability to return for all study visits for the 12-month duration of the study. * Participant agrees not to participate in another interventional study while participating in the present study.
Exclusion criteria
* Participant has evidence of choroidal neovascularization (CNV) in either eye. * Participant has GA secondary to any condition other than AMD in the study eye (e.g., drug-induced). * Participant has any ocular condition in the study eye that would progress during the course of the study and that could affect central vision or otherwise be a confounding factor. * Participant has the presence of intraocular inflammation (≥ trace cell or flare), macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreomacular traction, vitreous hemorrhage or aphakia (pseudophakia with or without an intact capsule is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment Emergent Adverse Events (TEAEs) | Up to 12 Months | An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 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 study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. TEAEs are defined as an AE observed after first administration of ASP3021 until 30 days after final administration of ASP3021. |
| Number of participants with Serious TEAEs | Up to 12 Months | A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or other situations. TEAEs are defined as an AE observed after first administration of ASP3021 until 30 days after final administration of ASP3021. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with intraocular pressure (IOP) abnormalities and/or AEs | Up to 12 months | Number of participants with potentially clinically significant IOP values. |
| Number of participants with ophthalmic examination abnormalities and/or AEs | Up to 12 months | Number of participants with potentially clinically significant ophthalmic examination values. |
| Number of participants with laboratory value abnormalities and/or AEs | Up to 12 months | Number of participants with potentially clinically significant laboratory values. |
| Number of participants with vital signs abnormalities and/or AEs | Up to 12 months | Number of participants with potentially clinically significant vital sign values. |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs | Up to 12 months | Number of participants with potentially clinically significant 12-Lead ECG values. |
| Mean rate of growth (slope) over 12 months | Up to 12 months | The growth (slope) over 12 months is estimated based on Geographic Atrophy (GA) area measured by fundus autofluorescence (FAF) (square root transformation). |
| Change from baseline in best corrected visual acuity (BCVA) | Baseline and up to 12 months | BCVA will be measured by Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters chart. |
| Change from baseline in low luminance best corrected visual acuity (LL BCVA) | Baseline and up to 12 months | LL BCVA will be measured by ETDRS letters chart. |
| Number of participants with antidrug antibodies (ADA) status | Up to 12 months | ADA will be recorded from the serum samples collected. |
| Number of participants with neutralizing antibodies (NAb) status for participant with positive ADA | Up to 12 months | NAb will be recorded from the serum samples collected. |
| PK of ASP3021 in plasma: Concentration | Up to 2 months | Concentration will be recorded from the PK plasma samples collected. |
| Pharmacokinetics (PK) of ASP3021 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) | Up to 12 months | Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected. |
Countries
Japan
Contacts
CONTACTAstellas Pharma Inc.
STUDY_DIRECTORAssociate Medical Director
Astellas Pharma Inc
Outcome results
None listed