A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

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 or history of idiopathic or autoimmune-associated uveitis in either eye.
• •Participant has significant media opacities, including cataract, which might interfere with visual acuity (VA), assessment of toxicity or retinal imaging (fundus photography, FAF, spectral domain optical coherence tomography \[SD-OCT\], enhanced depth imaging optical coherence tomography \[EDI OCT\], fluorescein angiography \[FA\] or indocyanine green angiography \[ICGA\]) in the course of the study in either eye. Participant should not be entered if there is likelihood that they will require cataract surgery in either eye during the study.
• •Participant has the presence of other causes of CNV, including pathologic myopia, high myopia (spherical equivalent of -8 diopters or more, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis in either eye.
• •Participant has any ocular or periocular infection (including blepharitis), or ocular surface inflammation in past 12 weeks in the study eye.
• •Participant has any sign of diabetic retinopathy in either eye.
• •Participant has BCVA of 20/320 or worse in the fellow eye.
• •Participant has any prior treatment for AMD (dry or wet) or any prior intravitreal (IVT) treatment for any indication in either eye, except oral supplements of vitamins and minerals.
• •Participant has concomitant treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve in either eye (including, but not limited to amiodarone, deferoxamine, chloroquine/hydroxychloroquine sulfate, tamoxifen, phenothiazines, ethambutol or fingolimod).
• •Participant has had any intraocular surgery or thermal laser treatment in the study eye within 3 months prior to screening, or any prior thermal laser treatment in the macular region, regardless of indication in the study eye.
• •Participant has a history of any of the following procedures in the study eye: posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant, or retinal detachment.
• •Participant has any previous therapeutic radiation in the region of the study eye.
• •Participant has a present or previous history of participation in a study of ASP3021.
• •Participant has a history of systemic treatment with any anti-complement agent in past or the likelihood of treatment with any systemic anti-complement agent during the study.
• •Participant has received any investigational therapy within 60 days or 5 half-lives, whichever is longer, prior to screening.
• •Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association \[NYHA\] Functional Class III or IV, or history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
• •Participant has a history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
• •Participant has clinically significant impaired renal (serum creatinine \> 2.5 mg/dL or status post-renal transplant or receiving dialysis) or hepatic function. Participants with these conditions may be enrolled after consultation with the medical monitor.
• •Participant has a history of stroke within 12 months prior to screening.
• •Participant has had any major surgical procedure within 1 month prior to screening.
• •Participant has any condition that makes the participant unsuitable for study participation.
• •Participant has a known or suspected serious allergy to the fluorescein dye and/or the indocyanine green dye used in angiography, povidone-iodine or hypersensitivity to ASP3021 or any components of the formulation used.