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 Uveitis Uveitis Pharmaceutical Solutions DE-109 Intravitreal Injections

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, Irvine accepting new patients
    Irvine California 92697 United States
  • USC Roski Eye Institute not yet accepting patients
    Los Angeles California 90032 United States

Details

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