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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01802866
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : July 2, 2017
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.

February 28, 2013
March 4, 2013
July 2, 2017
February 2013
April 2016   (Final data collection date for primary outcome measure)
Change from baseline in the total area of the GA lesion(s) [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT01802866 on Archive Site
  • Change from baseline in BCVA score [ Time Frame: 24 months ]
  • Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Geographic Atrophy
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Undecided
Acucela Inc.
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Acucela Medical Monitor Acucela Inc.
Acucela Inc.
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP