Phoenix, Arizona, United States
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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Notify MeKey information
Conditions
Age range
55 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
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
DrugTake orally once daily for 24 months
Other names: emixustat hydrochloride
Placebo
DrugTake orally once daily for 24 months
Primary outcomes
-
Change from baseline in the total area of the GA lesion(s)
Time frame: 24 months
Secondary outcomes
-
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
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.
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