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
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