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
| City: |
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Tuscon |
| State: |
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Arizona |
| Zip Code: |
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85704 |
| Conditions: |
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Neovascular Age-elated Macular Degeneration (Wet AMD) - Exudative Macular Degeneration |
| Purpose: |
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This study will assess the safety and efficacy of LFG316 in patients with age related
macular degeneration.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01535950 |
| Primary Contact: |
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Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: 1-888-669-6682
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| Backup Contact: |
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Novartis Pharmaceuticals
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| Location Contact: |
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Tuscon, Arizona 85704
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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