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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Active choroidal 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