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OpenTrials
Completed

NCT Number: NCT01802866

Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACU-4429

Drug

Take orally once daily for 24 months

Other names: emixustat hydrochloride

Placebo

Drug

Take orally once daily for 24 months

Primary outcomes

  1. Change from baseline in the total area of the GA lesion(s)

    Time frame: 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: SEATTLE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2013
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.