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.
Full Title of Study: “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
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2012
- Drug: ACU-4429
- ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days
- Drug: Matching placebo
- Matching placebo tablets taken orally once daily for 90 days
Arms, Groups and Cohorts
- Experimental: ACU-4429 tablet
- Placebo Comparator: Matching placebo tablet
Clinical Trial 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)
- Pharmacokinetics as measured by plasma ACU-4429 drug levels
- Time Frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90
Participating in This Clinical Trial
- Have a clinical diagnosis of geographic atrophy, as defined in the protocol
- Currently receiving or has received a medication prohibited by the protocol
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Acucela Inc.
- Otsuka Pharmaceutical Co., Ltd.
- Provider of Information About this Clinical Study
- Overall Official(s)
- John W Chandler, MD, Study Director, Acucela Inc.
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