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

Primary Purpose

Dry Age-related Macular Degeneration, Geographic Atrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ACU-4429
Matching placebo
Sponsored by
Kubota Vision Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Age-related Macular Degeneration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants of Arizona
  • Retina-Vitreous Associates Medical Group
  • Covance Clinical Research Unit, Inc.
  • National Ophthalmic Research Institute
  • Covance Clinical Research Unit, Inc.
  • Kresege Eye Institute
  • Associated Retinal Consultants, P.C. / William Beaumont Hospital
  • New York Eye and Ear Infirmary
  • Cleveland Clinic
  • Black Hills Regional Eye Institute
  • Covance Clinical Research Unit
  • Covance Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ACU-4429 tablet

Matching placebo tablet

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics as measured by plasma ACU-4429 drug levels

Full Information

First Posted
October 26, 2009
Last Updated
February 7, 2014
Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01002950
Brief Title
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
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 Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kubota Vision Inc.
Collaborators
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Age-related Macular Degeneration, Geographic Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACU-4429 tablet
Arm Type
Experimental
Arm Title
Matching placebo tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ACU-4429
Intervention Description
ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Matching placebo
Intervention Description
Matching placebo tablets taken orally once daily for 90 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Pharmacokinetics as measured by plasma ACU-4429 drug levels
Time Frame
Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W Chandler, MD
Organizational Affiliation
Kubota Vision Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Covance Clinical Research Unit, Inc.
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Covance Clinical Research Unit, Inc.
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kresege Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Associated Retinal Consultants, P.C. / William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Covance Clinical Research Unit
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Covance Clinical Research Unit, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33331670
Citation
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:CD013154. doi: 10.1002/14651858.CD013154.pub2.
Results Reference
derived

Learn more about this trial

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

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