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

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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.


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
Fort Myers, Florida 33912
2622
mi
from 98109
Fort Myers, FL
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Abilene, Texas 79606
1580
mi
from 98109
Abilene, TX
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Baltimore, Maryland 21287
2329
mi
from 98109
Baltimore, MD
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Danbury, Connecticut 06810
2406
mi
from 98109
Danbury, CT
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Edina, Minnesota 55435
1390
mi
from 98109
Edina, MN
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Fort Lauderdale, Florida 33313
2712
mi
from 98109
Fort Lauderdale, FL
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Forth Worth, Texas 76104
1662
mi
from 98109
Forth Worth, TX
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Pensacola, Florida 32504
2198
mi
from 98109
Pensacola, FL
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Torrance, California 90502
976
mi
from 98109
Torrance, CA
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Tuscon, Arizona 85704
1212
mi
from 98109
Tuscon, AZ
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West Columbia, South Carolina 29169
2320
mi
from 98109
West Columbia, SC
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