Subjects will be excluded from participation in the study if they meet any of
the following criteria:
1. History of, active or high risk of developing choroidal neovascularizition (CNV):
a) history of CNV associated with AMD in the study eye.
b) Active CNV in the study eye as confirmed by the central reading center.
c) Or a spherical equivalent >8 dipters of myopia in refractive error in either eye. If the subject has previously undergone refractive surgery, including cataract surgery, then the pre-operative refractive error can not be >8 diopters of myopia.
Note: choroidal neovascularization in the non-study eye is allowed regardless of treatment
2. Geographic atrophy associated with a condition other than AMD in either eye, or macular geographic atrophy with conitguous area of peripapillary atrophy in the study eye.
3. Presence in either eye of an active ocular disease that in the opinion of
the Investigator compromises or confounds visual function, including, but not limited to, uveitis, other macular diseases or uncontrolled glaucoma/ocular hypertension (rather than or equal to 25 mm Hg despite treatment with glaucoma medication)
4. History in the study eye of macular edema, external beam radiation,
macular surgery, or transpupillary thermotherapy.
5. History of any intraocular or ocular surface surgery in either eye within
3 months of screening.
6. Previous participation in an investigational study of ACU-4429.
7. Known serious allergy to the fluorescein sodium for injection in
angiography or hypersensitivity to ACU-4429 or any of the excipients in ACU-4429 tablets (ie, silicified microcrystalline cellulose, pregelatinized starch, colloidal silicon dioscide, and stearic acid).
8. Prohibited Medications: Use of a strong inhibitor or inducer of P450 enzyme CYP3A4 or a strong inducer of or a strong or moderate inhibitor of CYP2D6 beginning 4 weeks prior to screening and throughout the duration of the study period.
9. Any of the following laboratory abnormalities at screening:
a. Aspartate transaminase (AST)/alanine transaminase (ALT)
>3.0 x upper limit of normal (ULN)
b. Total bilirubin >1.5 x ULN
c. Impaired coagulation: International Normalized Ratio (INR),
prothrombin time (PT), or activated partial thromboplastin time
(aPTT) >1.25 x ULN
d. Hemoglobin A1c ≥7.5%
e. Impaired hematologic function: hemoglobin <11 g/dL;
neutrophil count <2.0 x 109/L; or platelet count <100 x 109/L.
Any laboratory screening test that meets the abnormality criteria stated
above can be repeated once within the 30 day period from screening to
10. Change in a systemic prescription medication or a medication newly
prescribed within 30 days prior to screening and between screening and baseline.
11. Participation during the study period in any study using an investigational study drug (within 30 days of screening) or interventional device (within 60 days of screening). Age-related Eye Disease Study (AREDS)-formulated vitamins (which have been under investigation) are allowed during the study period.
12. History of other disease, metabolic dysfunction, chronic immunosuppression, physical examination
finding, or clinical laboratory finding that in the opinion of the
Investigator gives reasonable suspicion of a disease or condition which
contraindicates the use of an investigational drug or might have affected
interpretation of the results of the study or rendered the subject at high
risk for treatment complications.
13. Current or history of cancer (except non-metastatic in situ carcinoma or
well-controlled carcinoma, [eg, basal cell carcinoma]) within 1 year of screening.
14. Any medical condition (eg, malabsorption, inflammatory bowel
disease, or hepatic or renal disease) that could alter the absorption,
metabolism, or elimination of drugs.
15. History of myocardial infarction, stroke, unstable ischemic heart
disease, uncontrolled cardiac arrhythmia, or hospitalization for
congestive heart failure within 6 months of screening.
16. Abnormal electrocardiogram (ECG) results that are considered by the
Investigator to be clinically significant at screening.
17. Female subjects who are pregnant or lactating.
18. Female subjects of childbearing potential (ie, not postmenopausal for at
least 2 years or not surgically sterile) who are not willing to practice a
medically accepted method of birth control with their non-surgically
sterile male sexual partner from screening through 30 days following
the completion of the study. Medically accepted methods of birth
control include hormonal contraceptives, nonhormonal intrauterine
contraceptive device with spermicide, condom with spermicide,
contraceptive sponge with spermicide, diaphragm with spermicide,
cervical cap with spermicide.
19. Male subjects who are not surgically sterile and are not willing to
practice a medically accepted method of birth control with their female
partner of childbearing potential (as listed above) from screening
through 30 days after completion of the study.
20. Unstable or poorly controlled medical or ophthalmic conditions that in
the opinion of the Investigator might interfere with the efficacy or
safety evaluation of the study drug, put the subject at any clinical risk,
negatively impact subject compliance, or jeopardize the subject’s ability
to complete the study.