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NCT00503022 Clinical Trial

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

Wet Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00503022
Other study ID # CACZ885F2201
Secondary ID
Status Completed
Phase Phase 1
First received July 17, 2007
Last updated December 19, 2007
Start date July 2006

Study information
Verified date December 2007
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swiss Agency for Therapeutic ProductsUnited Kingdom: Medicine and Healthcare products Regulatory Agency (MHRA)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 50 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ACZ885

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Changes in central macular edema from Baseline up to Month 6 Changes in best-corrected visual acuity from Baseline up to Month 6
See also
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Completed NCT03585556 - AAVCAGsCD59 for the Treatment of Wet AMD Phase 1
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Completed NCT03066258 - Safety and Tolerability of RGX-314 (Investigational Product) Gene Therapy for Neovascular AMD Trial Phase 1/Phase 2
Terminated NCT01086761 - Study of MP0112 Intravitreal Injection in Patients With Wet Age Related Macular Degeneration Phase 1
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