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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    200
  • sponsor
    Santen Inc.
Updated on 7 August 2021
Investigator
Santen Incorporated Clinical Operations
Primary Contact
Oftalmologia Global (2.6 mi away) Contact
+91 other location

Summary

This is a Phase III study to assess the efficacy and safety of DE-109 440 g 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 doublemasked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 g every 2 months for longer duration than appropriate for a placebo or sham control.

Details
Condition Non Infectious Uveitis
Treatment Sham Procedure, DE-109 Intravitreal Injections
Clinical Study IdentifierNCT03711929
SponsorSanten Inc.
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

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
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