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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00503022
First received: July 17, 2007
Last updated: December 19, 2007
Last verified: December 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00503022     History of Changes
Other Study ID Numbers: CACZ885F2201
Study First Received: July 17, 2007
Last Updated: December 19, 2007
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

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014