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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01802866
First received: February 28, 2013
Last updated: November 4, 2014
Last verified: November 2014

February 28, 2013
November 4, 2014
February 2013
July 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01802866 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
480
July 2016
July 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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01802866
4429-202
Not Provided
Acucela Inc.
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Study Director: Acucela Medical Monitor Acucela Inc.
Acucela Inc.
November 2014

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