Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Neovascular Age-related Macular Degeneration
In brief
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)
Key facts
- Study ID
- NCT01624636
- Run by
- Novartis Pharmaceuticals
- People needed
- 1
- Starts
- 2012-12-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Active choroidal neovascular AMD in at least one eye.
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Phoenix, Arizona, United States
- Novartis Investigative Site — Winter Haven, Florida, United States
- Novartis Investigative Site — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.