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

Phase 2

Completed

• Conditions: Dry Age-related Macular Degeneration; Geographic Atrophy
• Interventions: Drug: ACU-4429; Drug: Matching placebo

• Registration Number: NCT01002950
• Lead Sponsor: Kubota Vision Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-28
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2014-02
• Disposition First Submitted: 2014-02-07
• Disposition First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Disposition First Posted: 2014-03-11
• Last Update Posted: 2014-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACU-4429 tablet	ACU-4429	-
Matching placebo tablet	Matching placebo	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics as measured by plasma ACU-4429 drug levels	Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

Trial Locations

Locations (10)

New York Eye and Ear Infirmary; 🇺🇸 New York, New York, United States

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Covance Clinical Research Unit, Inc.; 🇺🇸 Dallas, Texas, United States

Associated Retinal Consultants, P.C. / William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

Kresege Eye Institute; 🇺🇸 Detroit, Michigan, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

National Ophthalmic Research Institute; 🇺🇸 Fort Meyers, Florida, United States

Covance Clinical Research Unit; 🇺🇸 Austin, Texas, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States