Status:
COMPLETED
Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride
Lead Sponsor:
Kubota Vision Inc.
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Geographic Atrophy
Eligibility:
All Genders
55+ years
Phase:
PHASE2
PHASE3
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 degen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT01802866
Start Date
February 1 2013
End Date
May 1 2016
Last Update
July 2 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix, Arizona, United States