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

Kubota Vision

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy; Dry Age-related Macular Degeneration

Treatments: Drug: Matching placebo; Drug: ACU-4429

Study type: Interventional

Funder types: Industry

Identifiers

NCT01002950

4429-201

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

ACU-4429 tablet

Experimental group

Treatment:

Drug: ACU-4429

Matching placebo tablet

Placebo Comparator group

Treatment:

Drug: Matching placebo