NCT00503022

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

July 17, 2007

Last Update Submit

December 19, 2007

Conditions

Wet Age-Related Macular Degeneration

Keywords

Wet age-related macular degenerationACZ885

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

ACZ885DRUG

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 50 years old, with aged related macular degeneration
  • Patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Bern, Switzerland

Location

Unknown Facility

Belfast, Northern Ireland, United Kingdom

Location

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

Liverpool, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Nottingham, United Kingdom

Location

Unknown Facility

Southampton, United Kingdom

Location

Unknown Facility

Wolverhampton, United Kingdom

Location

MeSH Terms

Interventions

canakinumab

Study Officials

  • Novartis EH 001 862 778 8300

    COREC,UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2007

First Posted

July 18, 2007

Study Start

July 1, 2006

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

CH(1)GB(7)