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 |
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
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