Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Geographic Atrophy Clinical Trial

— SEATTLE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802866
• Other study ID #: 4429-202
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 28, 2013
• Last updated: June 26, 2017
• Start date: February 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2017
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Drug:
• ACU-4429
Take orally once daily for 24 months
• Placebo
Take orally once daily for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Acucela Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the total area of the GA lesion(s)		24 months
Secondary	Change from baseline in BCVA score		24 months
Secondary	Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs		24 months