Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration

Novartis20 enrolled

Overview

This study evaluates the tolerability and safety of a single intravenous infusion of ACZ885. It also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Wet Age-Related Macular Degeneration

Interventions

ACZ885DRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male or female ≥ 50 years old, with aged related macular degeneration * Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration Exclusion criteria: * Active intraocular inflammation or ocular infection in the study eye * Eye disease that may result in visual loss during the study * Chronic therapy with topical, local or systemic corticosteroids. * Pregnant or nursing (lactating) women.

Locations (8)

Unnamed facility

Bern, Switzerland

Unnamed facility

Belfast, Northern Ireland, United Kingdom

Unnamed facility

Bristol, United Kingdom

Unnamed facility

Liverpool, United Kingdom

Outcomes

Primary Outcomes

Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, electrocardiograms (ECGs) and vital signs over 6 months, following single intravenous infusion of ACZ885.

Secondary Outcomes

Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6

Data from ClinicalTrials.gov

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