NCT01802866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

3.2 years

First QC Date

February 28, 2013

Last Update Submit

June 26, 2017

Conditions

Geographic Atrophy

Keywords

Geographic atrophyGADry AMD

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (2)

  • 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

Study Arms (4)

ACU-4429 2.5 mg

EXPERIMENTAL

2.5 mg tablet

Drug: ACU-4429

ACU-4429 5 mg

EXPERIMENTAL

5 mg tablet

Drug: ACU-4429

ACU-4429 10 mg

EXPERIMENTAL

10 mg tablet

Drug: ACU-4429

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ACU-4429DRUG

Take orally once daily for 24 months

Also known as: emixustat hydrochloride
ACU-4429 10 mgACU-4429 2.5 mgACU-4429 5 mg
PlaceboDRUG

Take orally once daily for 24 months

Placebo

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Phoenix, Arizona, United States

Location

Related Publications (2)

  • 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(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.

    PMID: 33331670DERIVED

  • 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.

    PMID: 29716784DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Interventions

emixustat

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Acucela Medical Monitor

    Kubota Vision Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

US(1)