Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) With Placebo for the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802866

Acronym

SEATTLE

Enrollment

508

Registered

2013-03-04

Start date

2013-02-28

Completion date

2016-05-31

Last updated

2017-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Keywords

Geographic atrophy, GA, Dry AMD

Brief summary

The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.

Interventions

DRUGACU-4429

Take orally once daily for 24 months

DRUGPlacebo

Take orally once daily for 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the total area of the GA lesion(s)	24 months

Secondary

Measure	Time frame
Change from baseline in BCVA score	24 months
Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026