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Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002950
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : March 11, 2014
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.

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.

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Geographic Atrophy Drug: ACU-4429 Drug: Matching placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Masked, Placebo-Controlled, Dose Escalation, Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACU-4429 in Subjects With Dry Age-Related Macular Degeneration (Geographic Atrophy)
Study Start Date : October 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ACU-4429 tablet Drug: ACU-4429
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days

Placebo Comparator: Matching placebo tablet Drug: Matching placebo
Matching placebo tablets taken orally once daily for 90 days

Primary Outcome Measures :
  1. Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire [ Time Frame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104) ]

Secondary Outcome Measures :
  1. Pharmacokinetics as measured by plasma ACU-4429 drug levels [ Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01002950

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United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Florida
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, United States, 32117
National Ophthalmic Research Institute
Fort Meyers, Florida, United States, 33912
United States, Hawaii
Covance Clinical Research Unit, Inc.
Honolulu, Hawaii, United States, 96813
United States, Michigan
Kresege Eye Institute
Detroit, Michigan, United States, 48201
Associated Retinal Consultants, P.C. / William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Texas
Covance Clinical Research Unit
Austin, Texas, United States, 78752
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
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Study Director: John W Chandler, MD Acucela Inc.

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Responsible Party: Acucela Inc. Identifier: NCT01002950    
Other Study ID Numbers: 4429-201
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical