Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (SEATTLE)

• Change from baseline in BCVA score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

• Drug: ACU-4429
  Take orally once daily for 24 months
  Other Name: emixustat hydrochloride
• Drug: Placebo
  Take orally once daily for 24 months

• Experimental: ACU-4429 2.5 mg
  2.5 mg tablet
  Intervention: Drug: ACU-4429
• Experimental: ACU-4429 5 mg
  5 mg tablet
  Intervention: Drug: ACU-4429
• Experimental: ACU-4429 10 mg
  10 mg tablet
  Intervention: Drug: ACU-4429
• Placebo Comparator: Placebo
  Includes identical tablets with only inactive ingredients (0 mg).
  Intervention: Drug: Placebo

Inclusion Criteria:

1. Males or females, age ≥55 years.
2. Clinical diagnosis of GA associated with AMD
3. Able and willing to provide written informed consent.
4. Able to reliably administer oral medication by self or with available assistance.

Exclusion Criteria:

1. Active CNV or presence of an active ocular disease.
2. Known serious allergy to the fluorescein sodium for injection in angiography.
3. Pre-specified laboratory abnormalities at screening.
4. Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)
5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding
6. Female subjects who are pregnant or lactating.
7. Female subjects of childbearing potential and male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control from screening through 30 days after completion of the study.
8. Unstable or poorly controlled medical or ophthalmic conditions