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Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (SEATTLE)

Primary Purpose

Geographic Atrophy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ACU-4429

Placebo

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic atrophy, GA, Dry AMD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

ACU-4429 2.5 mg

ACU-4429 5 mg

ACU-4429 10 mg

Placebo

Arm Description

2.5 mg tablet

5 mg tablet

10 mg tablet

Includes identical tablets with only inactive ingredients (0 mg).

Outcomes

Primary Outcome Measures

Change from baseline in the total area of the GA lesion(s)

Secondary Outcome Measures

Change from baseline in BCVA score

Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs

Full Information

NCT ID

NCT01802866

First Posted

February 28, 2013

Last Updated

June 26, 2017

Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01802866

Brief Title

Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Geographic Atrophy

Keywords

Geographic atrophy, GA, Dry AMD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

508 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACU-4429 2.5 mg

Arm Type

Experimental

Arm Description

2.5 mg tablet

Arm Title

ACU-4429 5 mg

Arm Type

Experimental

Arm Description

5 mg tablet

Arm Title

ACU-4429 10 mg

Arm Type

Experimental

Arm Description

10 mg tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Includes identical tablets with only inactive ingredients (0 mg).

Intervention Type

Drug

Intervention Name(s)

ACU-4429

Other Intervention Name(s)

emixustat hydrochloride

Intervention Description

Take orally once daily for 24 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Take orally once daily for 24 months

Primary Outcome Measure Information:

Title

Change from baseline in the total area of the GA lesion(s)

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Change from baseline in BCVA score

Time Frame

24 months

Title

Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Acucela Medical Monitor

Organizational Affiliation

Kubota Vision Inc.

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33331670

Citation

Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12:CD013154. doi: 10.1002/14651858.CD013154.pub2.

Results Reference

derived

PubMed Identifier

29716784

Citation

Rosenfeld PJ, Dugel PU, Holz FG, Heier JS, Pearlman JA, Novack RL, Csaky KG, Koester JM, Gregory JK, Kubota R. Emixustat Hydrochloride for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Clinical Trial. Ophthalmology. 2018 Oct;125(10):1556-1567. doi: 10.1016/j.ophtha.2018.03.059. Epub 2018 Apr 30. Erratum In: Ophthalmology. 2019 Mar;126(3):471-472.

Results Reference

derived

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Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride

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