LUMINA

Actively Recruiting // Clinical Trials // Laura Kopplin // Non-Infectious Posterior // Uveitis // Sep 30 2020

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

Study objective:

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.

Study design:

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.

Inclusion criteria:

  • Male or female patients ≥ 18 years of age
  • Non-Infectious Active Uveitis of the Posterior Segment

Exclusion criteria:

  • Females who are pregnant, nursing, or planning a pregnancy
  • Confirmed or suspected infectious uveitis

Contact Kelly Boyd with questions: 608-265-4589. For more information about this study: visit clinicaltrials.gov