Phase
Condition
Macular Degeneration
Aging
Myopic Macular Degeneration
Treatment
avacincaptad pegol
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has non-foveal central point involvement geographic atrophy (GA)secondary to age-related macular degeneration (AMD).
Participant has total GA area ≥ 2.5 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 ≥ 1.25mm^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 toallow for all imaging procedures, including good quality stereoscopic fundusphotography 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 medicalinterview and agrees to follow the contraceptive guidance from the time ofinformed consent through at least 40 days after final study interventionadministration.
Female participant must not be breastfeeding or lactating starting at screening andthroughout the investigational period and for 40 days after final study interventionadministration.
Female participant must not donate ova starting at first administration of studyintervention and throughout the investigational period and for 40 days after finalstudy intervention administration.
Male participant must agree to use contraception with female partner(s) ofchildbearing potential (including breastfeeding partner) throughout the treatmentperiod and for 40 days after final study intervention administration.
Male participant must agree to remain abstinent or use a condom with pregnantpartner(s) for the duration of the pregnancy throughout the investigational periodand for 40 days after final study intervention administration.
Male participant must not donate sperm during the treatment period and for 40 daysafter final study intervention administration.
Participant has ability to return for all study visits for the 12-month duration ofthe study.
Participant agrees not to participate in another interventional study whileparticipating in the present study.
Exclusion
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 thecourse of the study and that could affect central vision or otherwise be aconfounding factor.
Participant has the presence of intraocular inflammation (≥ trace cell or flare),macular hole, pathologic myopia, epiretinal membrane, evidence of significantvitreomacular traction, vitreous hemorrhage or aphakia (pseudophakia with or withoutan intact capsule is not an exclusion criteria) in the study eye.
Participant has the presence or history of idiopathic or autoimmune-associateduveitis in either eye.
Participant has significant media opacities, including cataract, which mightinterfere with visual acuity (VA), assessment of toxicity or retinal imaging (fundusphotography, FAF, spectral domain optical coherence tomography [SD-OCT], enhanceddepth 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 requirecataract 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 mmor more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, andmultifocal choroiditis in either eye.
Participant has any ocular or periocular infection (including blepharitis), orocular surface inflammation in past 12 weeks in the study eye.
Participant has any sign of diabetic retinopathy in either eye.
Participant has BCVA of 20/200 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 ofvitamins and minerals.
Participant has concomitant treatment with any ocular or systemic medication that isknown to be toxic to the lens, retina, or optic nerve in either eye (including, butnot limited to amiodarone, deferoxamine, chloroquine/hydroxychloroquine sulfate,tamoxifen, phenothiazines, ethambutol or fingolimod).
Participant has had any intraocular surgery or thermal laser treatment in the studyeye within 3 months prior to screening, or any prior thermal laser treatment in themacular 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 drainagedevice, 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 ofASP3021.
Participant has a history of systemic treatment with any anti-complement agent inpast or the likelihood of treatment with any systemic anti-complement agent duringthe 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 YorkHeart Association [NYHA] Functional Class III or IV, or history or clinical evidenceof unstable angina, acute coronary syndrome, myocardial infarction orrevascularization within last 6 months, or ventricular tachyarrhythmias requiringongoing treatment.
Participant has a history or evidence of clinically significant peripheral vasculardisease, such as intermittent claudication or prior amputation.
Participant has clinically significant impaired renal (serum creatinine > 2.5 mg/dLor status post-renal transplant or receiving dialysis) or hepatic function.Participants with these conditions may be enrolled after consultation with themedical 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 studyparticipation.
Participant has a known or suspected serious allergy to the fluorescein dye and/orthe indocyanine green dye used in angiography, povidone iodine or hypersensitivityto ASP3021 or any components of the formulation used.
Study Design
Connect with a study center
Fukushima Medical University Hospital
Fukushima-shi, Fukushima
JapanActive - Recruiting
Kyoto University Hospital
Kyoto-shi, Kyoto
JapanActive - Recruiting
Mie University Hospital
Tsu-shi, Mie
JapanActive - Recruiting
University of the Ryukyus hospital
Ginowan-shi, Okinawa
JapanActive - Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu-shi, Shizuoka
JapanActive - Recruiting
Nihon University Hospital
Chiyoda-ku, Tokyo
JapanActive - Recruiting
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