Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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.

Key facts

Study ID

NCT01802866

Run by

Kubota Vision Inc.

People needed

508

Starts

2013-02-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-02

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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