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

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.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bern, Switzerland

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACZ885

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, Double-Masked, Multi-Center Phase I Study of 6 Months Duration to Assess the Safety and Tolerability of Intravenous ACZ885 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Important dates

Study start: 2006
First posted: Jul 18, 2007
Registry last updated: Dec 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed