LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:November 19, 2018
End Date:April 17, 2021
Contact:Santen Inc. Clinical Operations
Email:clinicaltrials@santen.com
Phone:(415)-268-9169

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LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.

This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months
in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).

There is a 6-month, single-arm, open-label period after completion of the 6-month double-
masked, controlled period allows the evaluation of the efficacy and safety of intravitreal
injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo
or sham control.


Inclusion Criteria:

Non-Infectious Active Uveitis of the Posterior Segment

Exclusion Criteria:

Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected
infectious uveitis
We found this trial at
35
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Hamden, Connecticut 06518
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Austin, Texas 78705
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Boston, Massachusetts 02114
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Durham, North Carolina 27705
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Golden, Colorado 80401
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Houston, Texas 77030
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Houston, Texas 77025
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Independence, Missouri 64055
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Indianapolis, Indiana 46290
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Indianapolis, Indiana 46290
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Lexington, Kentucky 40509
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Marietta, Georgia 30060
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Mountain View, California 94040
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Nashville, Tennessee 37232
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New York, New York 10021
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Norfolk, Virginia 23502
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Oak Park, Illinois 60304
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Palisades Park, New Jersey 07650
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Palo Alto, California 94303
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Royal Oak, Michigan 48073
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4344 Central Avenue North
Saint Petersburg, Florida 33711
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San Antonio, Texas 78217
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San Antonio, Texas 78240
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San Francisco, California 94107
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Tucson, Arizona 85704
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Urbana, Illinois 61801
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Winston-Salem, North Carolina 27157
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