Summary

for people ages 18 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

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.

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.

Keywords

Non Infectious UveitisUveitisPharmaceutical SolutionsDE-109 Intravitreal InjectionsSham Procedure

Eligibility

You can join if…

Open to people ages 18 years and up

Non-Infectious Active Uveitis of the Posterior Segment

You CAN'T join if...

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

Locations

  • University of California, Irvinenot yet accepting patients
    IrvineCalifornia92697United States
  • Retina-Vitreous Associates Medical Groupaccepting new patients
    Beverly HillsCalifornia90211United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Santen Inc.
ID
NCT03711929
Phase
Phase 3
Study Type
Interventional
Last Updated