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

Kubota Vision

Status and phase: Completed; Phase 3; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: ACU-4429; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802866

4429-202

Details and patient eligibility

About

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.

Enrollment: 508 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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508 participants in 4 patient groups, including a placebo group

ACU-4429 2.5 mg

Experimental group

Description:

2.5 mg tablet

Treatment:

Drug: ACU-4429

ACU-4429 5 mg

Experimental group

Description:

5 mg tablet

Treatment:

Drug: ACU-4429

ACU-4429 10 mg

Experimental group

Description:

10 mg tablet

Treatment:

Drug: ACU-4429

Placebo

Placebo Comparator group

Description:

Includes identical tablets with only inactive ingredients (0 mg).

Treatment:

Drug: Placebo