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

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01002950
First received: October 26, 2009
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Dry Age-related Macular Degeneration
Geographic Atrophy
Drug: ACU-4429
Drug: Matching placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics as measured by plasma ACU-4429 drug levels [ Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002950

Locations
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.
Investigators
Study Director: John W Chandler, MD Acucela Inc.
  More Information

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01002950     History of Changes
Other Study ID Numbers: 4429-201
Study First Received: October 26, 2009
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 22, 2014