Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Completed · Phase 2 · Has a placebo group
Conditions studied: Neovascular Age-elated Macular Degeneration (Wet AMD), Exudative Macular Degeneration
In brief
This study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.
Key facts
- Study ID
- NCT01535950
- Run by
- Novartis Pharmaceuticals
- People needed
- 43
- Starts
- 2012-02-01
- Expected to finish
- 2013-07-01
- 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…
- Best corrected visual acuity (ETDRS scale) of 60 letters or less in the study eye.
- An active choroidal neovascular membrane attributable to neovascular AMD in at least one eye.
- History of treatment (at any time) with at least 3 doses of anti-VEGF therapy in the study eye.
You may not qualify if…
- History of recurrent non-response to anti-VEGF therapy in the study eye.
- In the study eye, retinal disease other than AMD (benign conditions of the vitreous and peripheral retina are not exclusionary).
- Choroidal neovascularization due to a cause other than AMD.
- In the study eye, media opacity that, in the investigator's opinion, could interfere with conduct of the study.
- History of infectious uveitis or endophthalmitis in either eye.
- Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab, bevacizumab, pegaptanib or other VEGF inhibitor.
- Any of the following within 90 days prior to dosing: photodynamic therapy or laser photocoagulation in the study eye; intravitreal steroid in the study eye; or intraocular surgery (including cataract surgery) in the study eye
Where it is running
- Novartis Investigative Site — Tucson, Arizona, United States
- Novartis Investigative Site — Torrance, California, United States
- Novartis Investigative Site — Fort Myers, Florida, United States
- Novartis Investigative Site — Baltimore, Maryland, United States
- Novartis Investigative Site — West Columbia, South Carolina, United States
- Novartis Investigative Site — Abilene, Texas, United States
- Novartis Investigative Site — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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