Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:December 2012
End Date:February 2014
Contact:Novartis Pharmaceuticals
Phone:+1(862)778-8300

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A Multiple Dose, Two-cohort Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous LFG316 in Patients With Neovascular Age-related Macular Degeneration


This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and
efficacy of successive intravenous (IV) doses of LFG316 in eligible patients with
neovascular age-related macular degeneration (AMD)


Inclusion Criteria:

- Active chroidal neovascular AMD in at least one eye.

Exclusion Criteria:

- Retinal disease other than AMD that, in the investigator's opinion, would interfere
with safety or study conduct.

- Choroidal neovascularization due to a cause other than AMD.

- In the study eye, media opacity that, in the investigator's opinion, would interfere
with study conduct.

- Any disease or concomitant (or recent) medication expected to cause systemic
immunosuppression.

- History of meningococcal meningitis in the past 10 years, or any history of recurrent
meningitis.

- History of hospitalization for pneumococcal pneumonia within the past 3 years.

- History of serious systemic infection within the past 12 months.

- Any of the following treatments to the study eye within 7 days prior to study drug
dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other
VEGF inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
4
sites
Miami, Florida 33136
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Boston, Massachusetts 02118
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Boston, MA
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Cincinatti, Ohio 45219
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Phoenix, Arizona 85012
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Phoenix, AZ
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