Clinical trial NCT01002950: Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Age-related Macular Degeneration
Geographic Atrophy
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2009-10-28
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire
timeFrame: Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104)
Secondary outcomes:
measure: Pharmacokinetics as measured by plasma ACU-4429 drug levels
timeFrame: Baseline; Treatment Days 2, 7, 14, 30, 60 and 90
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Florida
city: Fort Meyers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Honolulu
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Hawaii
city: Detroit
country: United States
facility: Kresege Eye Institute
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C. / William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Austin
country: United States
facility: Covance Clinical Research Unit
state: Texas
city: Dallas
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Texas
Study officials:
affiliation: Kubota Vision Inc.
name: John W Chandler, MD
role: STUDY_DIRECTOR
References:
citation: Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2.