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

Kubota Vision Inc.72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Interventions

ACU-4429DRUG

ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days

Matching placeboDRUG

Matching placebo tablets taken orally once daily for 90 days

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (12)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Covance Clinical Research Unit, Inc.

Daytona Beach, Florida, United States

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

Time frame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90

Data from ClinicalTrials.gov

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