NCT01002950

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

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

October 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2.7 years

First QC Date

October 26, 2009

Last Update Submit

February 7, 2014

Conditions

Dry Age-related Macular DegenerationGeographic Atrophy

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire

    Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)

Secondary Outcomes (1)

  • Pharmacokinetics as measured by plasma ACU-4429 drug levels

    Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

Study Arms (2)

ACU-4429 tablet

EXPERIMENTAL
Drug: ACU-4429

Matching placebo tablet

PLACEBO COMPARATOR
Drug: Matching placebo

Interventions

ACU-4429DRUG

ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days

ACU-4429 tablet
Matching placeboDRUG

Matching placebo tablets taken orally once daily for 90 days

Matching placebo tablet

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have a clinical diagnosis of geographic atrophy, as defined in the protocol

You may not qualify if:

  • Currently receiving or has received a medication prohibited by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, 32117, United States

Location

National Ophthalmic Research Institute

Fort Meyers, Florida, 33912, United States

Location

Covance Clinical Research Unit, Inc.

Honolulu, Hawaii, 96813, United States

Location

Kresege Eye Institute

Detroit, Michigan, 48201, United States

Location

Associated Retinal Consultants, P.C. / William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Covance Clinical Research Unit

Austin, Texas, 78752, United States

Location

Covance Clinical Research Unit, Inc.

Dallas, Texas, 75247, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Geographic Atrophy

Interventions

emixustat

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • John W Chandler, MD

    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

October 26, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

March 11, 2014

Record last verified: 2014-02

Locations

US(12)