Back to resultsSafety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration
Primary Purpose
Wet Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ACZ885
Sponsored by
About this trial
This is an interventional treatment trial for Wet Age-Related Macular Degeneration focused on measuring Wet age-related macular degeneration, ACZ885
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503022
Brief Title
Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Age-Related Macular Degeneration
Keywords
Wet age-related macular degeneration, ACZ885
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ACZ885
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis EH 001 862 778 8300
Organizational Affiliation
COREC,UK
Official's Role
Study Chair
Facility Information:
City
Bern
Country
Switzerland
City
Belfast, Northern Ireland
Country
United Kingdom
City
Bristol
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
London
Country
United Kingdom
City
Nottingham,
Country
United Kingdom
City
Southampton
Country
United Kingdom
City
Wolverhampton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability of an Intravenous Infusion of ACZ885 in Patients With Wet Age-Related Macular Degeneration
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