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 (LUMINA)
Sponsor: Santen, Inc.
Principal Investigator: Laura Kopplin, MD, PhD
Study Coordinator: Kelly Boyd
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.
The study duration is approximately 12 months. The first 6 months is the Masked Period where subjects will be randomized into one of three groups:
1. Intravitreal injection of Sirolimus 440 µg in the study eye(s) every 2 months
2. Sham procedure administered to the study eye(s) every 2 months
3. Intravitreal injection of Sirolimus at undisclosed, fixed dose (within range of 44 µg to 880 µg) in the study eye(s) every 2 months
The second 6 months is the Open-Label Period where all subjects will receive Sirolimus 440 µg every 2 months.
Male or female patients ≥ 18 years of age
Non-Infectious Active Uveitis of the Posterior Segment
Females who are pregnant, nursing, or planning a pregnancy