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SEATTLE: Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Sponsor
Kubota Vision Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01802866
Collaborator
Otsuka Pharmaceutical Co., Ltd. (Industry)
508
Enrollment
1
Location
4
Arms
38.9
Duration (Months)
13
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
508 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ACU-4429 2.5 mg

2.5 mg tablet

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

    		•
    Experimental: ACU-4429 5 mg

    5 mg tablet

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

    		•
    Experimental: ACU-4429 10 mg

    10 mg tablet

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

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    Take orally once daily for 24 months

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in the total area of the GA lesion(s) [24 months]

    Secondary Outcome Measures

    1. Change from baseline in BCVA score [24 months]

    2. Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States

    Sponsors and Collaborators

    • Kubota Vision Inc.
    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    • Study Director: Acucela Medical Monitor, Kubota Vision Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kubota Vision Inc.
    ClinicalTrials.gov Identifier:
    NCT01802866
    Other Study ID Numbers:
    • 4429-202
    First Posted:
    Mar 4, 2013
    Last Update Posted:
    Jul 2, 2017
    Last Verified:
    Jun 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Kubota Vision Inc.
    Geographic atrophy
    GA
    Dry AMD
    Additional relevant MeSH terms:
    Geographic Atrophy
    Atrophy

    Study Results

    No Results Posted as of Jul 2, 2017