Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
NCT ID: NCT01002950
Last Updated: 2014-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2009-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACU-4429 tablet
ACU-4429
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
Matching placebo tablet
Matching placebo
Matching placebo tablets taken orally once daily for 90 days
Interventions
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ACU-4429
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
Matching placebo
Matching placebo tablets taken orally once daily for 90 days
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Kubota Vision Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John W Chandler, MD
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Covance Clinical Research Unit, Inc.
Daytona Beach, Florida, United States
National Ophthalmic Research Institute
Fort Meyers, Florida, United States
Covance Clinical Research Unit, Inc.
Honolulu, Hawaii, United States
Kresege Eye Institute
Detroit, Michigan, United States
Associated Retinal Consultants, P.C. / William Beaumont Hospital
Royal Oak, Michigan, United States
New York Eye and Ear Infirmary
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Covance Clinical Research Unit
Austin, Texas, United States
Covance Clinical Research Unit, Inc.
Dallas, Texas, United States
Countries
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References
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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.
Other Identifiers
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4429-201
Identifier Type: -
Identifier Source: org_study_id
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