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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503022
First Posted: July 18, 2007
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503022


Locations
Switzerland
Bern, Switzerland
United Kingdom
Belfast, Northern Ireland, United Kingdom
Bristol, United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Nottingham,, United Kingdom
Southampton, United Kingdom
Wolverhampton, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis EH 001 862 778 8300 COREC,UK
  More Information

ClinicalTrials.gov Identifier: NCT00503022     History of Changes
Other Study ID Numbers: CACZ885F2201
First Submitted: July 17, 2007
First Posted: July 18, 2007
Last Update Posted: December 28, 2007
Last Verified: December 2007

Keywords provided by Novartis:
Wet age-related macular degeneration
ACZ885

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs