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

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ClinicalTrials.gov Identifier: NCT01802866
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Kubota Vision Inc.

Study Description
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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
Geographic Atrophy Drug: ACU-4429 Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : February 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ACU-4429 2.5 mg
2.5 mg tablet
 Drug: ACU-4429
Take orally once daily for 24 months
Other Name: emixustat hydrochloride
Experimental: ACU-4429 5 mg
5 mg tablet
 Drug: ACU-4429
Take orally once daily for 24 months
Other Name: emixustat hydrochloride
Experimental: ACU-4429 10 mg
10 mg tablet
 Drug: ACU-4429
Take orally once daily for 24 months
Other Name: 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
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Primary Outcome Measures :
  1. Change from baseline in the total area of the GA lesion(s) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Change from baseline in BCVA score [ Time Frame: 24 months ]
  2. Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802866


Locations
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United States, Arizona
Phoenix, Arizona, United States
Sponsors and Collaborators
Kubota Vision Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Acucela Medical Monitor Kubota Vision Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kubota Vision Inc.
ClinicalTrials.gov Identifier: NCT01802866    
Other Study ID Numbers: 4429-202
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kubota Vision Inc.:
Geographic atrophy
GA
Dry AMD
Additional relevant MeSH terms:
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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases