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.
IZERVAY has received marketing approval in Japan. The study will continue as a post marketing study in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
intravitreal injection
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGFukushima Medical University Hospital
Fukushima, Fukushima, Japan
RECRUITINGKagawa University Hospital
Kita-gun, Kagawa-ken, Japan
RECRUITINGYokohama City University Medical Center
Yokohama, Kanagawa, Japan
RECRUITINGKyoto University Hospital
Kyoto, Kyoto, Japan
RECRUITINGMie University Hospital
Tsu, Mie-ken, Japan
RECRUITINGNagasaki University Hospital
Nagasaki, Nagasaki, Japan
RECRUITINGUniversity of the Ryukyus hospital
Ginowan-shi, Okinawa, Japan
RECRUITINGKansai Medical University Hospital
Hirakata-shi, Osaka, Japan
RECRUITINGThe University of Osaka Hospital
Suita-shi, Osaka, Japan
RECRUITING...and 5 more locations
Number of participants with Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to 12 Months
Number of participants with Serious TEAEs
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.
Time frame: Up to 12 Months
Number of participants with intraocular pressure (IOP) abnormalities and/or AEs
Number of participants with potentially clinically significant IOP values.
Time frame: Up to 12 months
Number of participants with ophthalmic examination abnormalities and/or AEs
Number of participants with potentially clinically significant ophthalmic examination values.
Time frame: Up to 12 months
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 12 months
Number of participants with vital signs abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 12 months
Number of participants with 12-lead electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant 12-Lead ECG values.
Time frame: Up to 12 months
Mean rate of growth (slope) over 12 months
The growth (slope) over 12 months is estimated based on Geographic Atrophy (GA) area measured by fundus autofluorescence (FAF) (square root transformation).
Time frame: Up to 12 months
Change from baseline in best corrected visual acuity (BCVA)
BCVA will be measured by Early Treatment Diabetic Retinopathy Study \[ETDRS\] letters chart.
Time frame: Baseline and up to 12 months
Change from baseline in low luminance best corrected visual acuity (LL BCVA)
LL BCVA will be measured by ETDRS letters chart.
Time frame: Baseline and up to 12 months
Number of participants with antidrug antibodies (ADA) status
ADA will be recorded from the serum samples collected.
Time frame: Up to 12 months
Number of participants with neutralizing antibodies (NAb) status for participant with positive ADA
NAb will be recorded from the serum samples collected.
Time frame: Up to 12 months
PK of ASP3021 in plasma: Concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to 2 months
Pharmacokinetics (PK) of ASP3021 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the pharmacokinetic (PK) plasma samples collected.
Time frame: Up to 12 months
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