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

This study has been completed.

First Received: July 17, 2007 Last Updated: December 19, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00503022

Purpose

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.

Condition	Intervention	Phase
Wet Age-Related Macular Degeneration	Drug: ACZ885	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema Macular Degeneration

Drug Information available for: ACZ 885

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	20
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503022

Locations

Switzerland

Bern, Switzerland
United Kingdom

Liverpool, United Kingdom

Nottingham,, United Kingdom

Bristol, United Kingdom

Southampton, United Kingdom

Wolverhampton, United Kingdom

Belfast, Northern Ireland, United Kingdom

London, United Kingdom

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis EH 001 862 778 8300

COREC,UK

More Information

No publications provided

Study ID Numbers:	CACZ885F2201
Study First Received:	July 17, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00503022 History of Changes
Health Authority:	Switzerland: Swiss Agency for Therapeutic Products; United Kingdom: Medicine and Healthcare products Regulatory Agency (MHRA)

Keywords provided by Novartis:

Wet age-related macular degeneration
ACZ885

Study placed in the following topic categories:

Uveal Diseases
Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on September 11, 2009