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 |
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.
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
sites
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University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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