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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
Recruiting
Trial ID: NCT03711929
Purpose
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.
Official Title
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.
Stanford Investigator(s)
Diana Do, MD
Professor of Ophthalmology
Eligibility
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
Intervention(s):
drug: DE-109 Intravitreal Injections
other: Sham Procedure
drug: DE-109 Intravitreal Injections
drug: DE-109 Intravitreal Injections (Open Label)
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305