Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
NCT ID: NCT01535950
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2012-02-29
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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LFG316
LFG316
Sham
Placebo
Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Interventions
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LFG316
Placebo
Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
90 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Related Links
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Results for CLFG316A2202 from the Novartis Clinical Trials website
Other Identifiers
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CLFG316A2202
Identifier Type: -
Identifier Source: org_study_id