A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 μg DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye (Lumina)
Sponsor: Santen Incorporated
Principal Investigator: Laura Kopplin, MD
Study Coordinator: Kelly Boyd
This study will compare DE-109 with sham for the treatment of active, non-infectious uveitis of the posterior segment of the eye.
Patients will be randomly assigned to one out of two study treatment groups. The study will compare DE-10 every 2 months to sham for 6 months followed by a 6-month, open-label period in which all subjects will receive DE-109 every 2 months.
Diagnosis and Key Eligibility Criteria:
Male or female subjects least 18 years of age with diagnosis of active uveitis of the posterior segment determined to be non-infectious and 20/400 Snellen or better in the study eye.
Duration of study: Approximately 1 year.
For more information, contact Kelly Boyd 608-265-4589.