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

Geographic Atrophy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002950
• Other study ID #: 4429-201
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: February 7, 2014
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: February 2014
• Source: Acucela Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Dry Age-related Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Cleveland Clinic	Cleveland	Ohio
United States	Covance Clinical Research Unit, Inc.	Dallas	Texas
United States	Covance Clinical Research Unit, Inc.	Daytona Beach	Florida
United States	Kresege Eye Institute	Detroit	Michigan
United States	National Ophthalmic Research Institute	Fort Meyers	Florida
United States	Covance Clinical Research Unit, Inc.	Honolulu	Hawaii
United States	New York Eye and Ear Infirmary	New York	New York
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Associated Retinal Consultants, P.C. / William Beaumont Hospital	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Acucela Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire		Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)	Yes
Secondary	Pharmacokinetics as measured by plasma ACU-4429 drug levels		Baseline; Treatment Days 2, 7, 14, 30, 60 and 90	No