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

June 26, 2017 updated by: Kubota Vision Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Includes identical tablets with only inactive ingredients (0 mg).
Drug: Placebo
Take orally once daily for 24 months
Experimental: ACU-4429 2.5 mg
2.5 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Names:
  • emixustat hydrochloride
Experimental: ACU-4429 5 mg
5 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Names:
  • emixustat hydrochloride
Experimental: ACU-4429 10 mg
10 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Names:
  • emixustat hydrochloride

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in BCVA score
Time Frame: 24 months
24 months
Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Acucela Medical Monitor, Kubota Vision Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 28, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4429-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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