Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Phase 2

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: ACU-4429; Drug: Placebo

• Registration Number: NCT01802866
• Lead Sponsor: Kubota Vision Inc.

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 degeneration.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-02-28
• Study First Posted: 2013-03-04
• Primary Completion: 2016-04
• Study Completion: 2016-05
• Status Verified: 2017-06
• Disposition First Submitted: 2017-06-26
• Disposition First Submitted QC: 2017-06-26
• Last Update Submitted: 2017-06-26
• Disposition First Posted: 2017-07-02
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACU-4429 2.5 mg	ACU-4429	2.5 mg tablet
ACU-4429 5 mg	ACU-4429	5 mg tablet
ACU-4429 10 mg	ACU-4429	10 mg tablet
Placebo	Placebo	Includes identical tablets with only inactive ingredients (0 mg).

Primary Outcome Measures

Name	Time	Method
Change from baseline in the total area of the GA lesion(s)	24 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA score	24 months
Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs	24 months