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

Tracking Information
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; (submitted: February 28, 2013)	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; (submitted: February 28, 2013)	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 ]
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
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Geographic Atrophy
Intervention ICMJE	Drug: ACU-4429 Take orally once daily for 24 months Other Name: emixustat hydrochloride; Drug: Placebo Take orally once daily for 24 months
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 31, 2016)	508
Original Estimated Enrollment ICMJE; (submitted: February 28, 2013)	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: Males or females, age ≥55 years.; Clinical diagnosis of GA associated with AMD; Able and willing to provide written informed consent.; Able to reliably administer oral medication by self or with available assistance. Exclusion Criteria: Active CNV or presence of an active ocular disease.; Known serious allergy to the fluorescein sodium for injection in angiography.; Pre-specified laboratory abnormalities at screening.; Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening); History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding; Female subjects who are pregnant or lactating.; 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.; Unstable or poorly controlled medical or ophthalmic conditions
Sex/Gender	Sexes Eligible for Study: All
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	Plan to Share IPD: Undecided
Responsible Party	Acucela Inc.
Study Sponsor ICMJE	Acucela Inc.
Collaborators ICMJE	Otsuka Pharmaceutical Co., Ltd.
Investigators ICMJE	Study Director: Acucela Medical Monitor Acucela Inc.
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