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
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Sponsor:
Acucela Inc.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | February 28, 2013 | |||
First Posted Date ICMJE | March 4, 2013 | |||
Last Update Posted Date | July 2, 2017 | |||
Study Start Date ICMJE | February 2013 | |||
Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change from baseline in the total area of the GA lesion(s) [ Time Frame: 24 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01802866 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Geographic Atrophy | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
508 | |||
Original Estimated Enrollment ICMJE |
440 | |||
Actual Study Completion Date | May 2016 | |||
Actual Primary Completion Date | April 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 55 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01802866 | |||
Other Study ID Numbers ICMJE | 4429-202 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Acucela Inc. | |||
Study Sponsor ICMJE | Acucela Inc. | |||
Collaborators ICMJE | Otsuka Pharmaceutical Co., Ltd. | |||
Investigators ICMJE |
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PRS Account | Acucela Inc. | |||
Verification Date | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |