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

Age: 18 - 50 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: November 19, 2018

End Date: June 30, 2022

Contact Information:
Katy Tai
212-979-4251
Summary:

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.

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