NCT01002950
Completed
Phase 2
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)
Kubota Vision Inc.10 sites in 1 country72 target enrollmentOctober 2009
Overview
- Phase
- Phase 2
- Intervention
- ACU-4429
- Conditions
- Dry Age-related Macular Degeneration
- Sponsor
- Kubota Vision Inc.
- Enrollment
- 72
- Locations
- 10
- Primary Endpoint
- Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
ACU-4429 tablet
Intervention: ACU-4429
Matching placebo tablet
Intervention: Matching placebo
Outcomes
Primary Outcomes
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 Outcomes
- Pharmacokinetics as measured by plasma ACU-4429 drug levels(Baseline; Treatment Days 2, 7, 14, 30, 60 and 90)
Study Sites (10)
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