Safety and Tolerability of Intravenous LFG316 in Wet Age-related Macular Degeneration (AMD).
NCT ID: NCT01624636
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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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2012-12-31
2013-05-31
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
QUADRUPLE
Study Groups
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Placebo
Placebo
LFG316: 10 mg/kg (2 doses in cohort 1)
LFG316
LFG316: 20 mg/kg (2 doses in cohort 1, 3 doses in cohort 2).
LFG316
Interventions
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Placebo
LFG316
LFG316
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Choroidal neovascularization due to a cause other than AMD.
* In the study eye, media opacity that, in the investigator's opinion, would interfere with study conduct.
* Any disease or concomitant (or recent) medication expected to cause systemic immunosuppression.
* History of meningococcal meningitis in the past 10 years, or any history of recurrent meningitis.
* History of hospitalization for pneumococcal pneumonia within the past 3 years.
* History of serious systemic infection within the past 12 months.
* Any of the following treatments to the study eye within 7 days prior to study drug dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor.
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
Phoenix, Arizona, United States
Novartis Investigative Site
Winter Haven, Florida, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Countries
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Related Links
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Results for CLFG316A2201 from the Novartis Clinical Trials website
Other Identifiers
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CLFG316A2201
Identifier Type: -
Identifier Source: org_study_id