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Completed

NCT Number: NCT01002950

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

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.

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Key information

Conditions

Dry Age-related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Consultants of Arizona, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACU-4429

Drug

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

Matching Placebo

Drug

Matching placebo tablets taken orally once daily for 90 days

Primary outcomes

  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 outcomes

  1. Pharmacokinetics as measured by plasma ACU-4429 drug levels

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

Sponsors and collaborators

Lead sponsor

Kubota Vision Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2009
Registry last updated
Mar 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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