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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01002950

Enrollment

Registered

2009-10-28

Start date

2009-10-31

Completion date

2012-10-31

Last updated

2014-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Age-related Macular Degeneration, Geographic Atrophy

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.

Interventions

DRUGACU-4429

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

DRUGMatching placebo

Matching placebo tablets taken orally once daily for 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026