Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:4/21/2016
Start Date:February 2013
End Date:July 2016

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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.


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
We found this trial at
1
site
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mi
from
Phoenix, AZ
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