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

February 7, 2014 updated by: Kubota Vision Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching placebo tablet
Drug: Matching placebo
Matching placebo tablets taken orally once daily for 90 days
Experimental: ACU-4429 tablet
Drug: ACU-4429
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics as measured by plasma ACU-4429 drug levels
Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90
Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kubota Vision Inc.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: John W Chandler, MD, Kubota Vision Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

March 11, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4429-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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