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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Otsuka Pharmaceutical Co., Ltd.

Information provided by (Responsible Party):

Acucela Inc.

ClinicalTrials.gov Identifier:

NCT01802866

First received: February 28, 2013

Last updated: November 4, 2014

Last verified: November 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2013

Last Updated Date

November 4, 2014

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

July 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 ] [ Designated as safety issue: No ]

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

Change from baseline in BCVA score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Active, not recruiting

Estimated Enrollment ^ICMJE

480

Estimated Completion Date

July 2016

Estimated Primary Completion Date

July 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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

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

Not Provided

Responsible Party

Acucela Inc.

Study Sponsor ^ICMJE

Acucela Inc.

Collaborators ^ICMJE

Otsuka Pharmaceutical Co., Ltd.

Investigators ^ICMJE

Study Director:

Acucela Medical Monitor

Acucela Inc.

Information Provided By

Acucela Inc.

Verification Date

November 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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