Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 55 - 90 |
Updated: | 1/1/2014 |
Start Date: | February 2012 |
End Date: | August 2013 |
Contact: | Novartis Pharmaceuticals |
Phone: | 1-888-669-6682 |
A Multicenter, Randomized, Sham-controlled, Repeat-dose Study to Assess the Safety, Tolerability, Serum Pharmacokinetics, and Efficacy of Intravitreal LFG316 in Patients With Neovascular Age-related Macular Degeneration
This study will assess the safety and efficacy of LFG316 in patients with age related
macular degeneration.
macular degeneration.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
11
sites
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