Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: ACU-4429
    • Take orally once daily for 24 months
  • Drug: Placebo
    • Take orally once daily for 24 months

Arms, Groups and Cohorts

  • Experimental: ACU-4429 2.5 mg
    • 2.5 mg tablet
  • Experimental: ACU-4429 5 mg
    • 5 mg tablet
  • Experimental: ACU-4429 10 mg
    • 10 mg tablet
  • Placebo Comparator: Placebo
    • Includes identical tablets with only inactive ingredients (0 mg).

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in the total area of the GA lesion(s)
    • Time Frame: 24 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Acucela Inc.
  • Collaborator
    • Otsuka Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Acucela Medical Monitor, Study Director, Acucela Inc.

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