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Santen LUMINA - Uveitis Non-infectious

Study Assessing an Intravitreal Injection for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Study Description:

Condition or DiseaseIntervention / Treatment PhaseSponsor Status 
 Non Infectious Uveitis DE-109 Sirolimus
Intravitreal Injection
 Santen Inc. Enrolling

 

 

 

This study will assess the efficacy and safety of sirolimus DE-109 every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).

Intervetion/Treatment Arms:  Subjects are randomly assigned to one of these:

  • Test Arm:  Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 subjects).
  • Control Arm:  Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 80 subjects). The sham procedure mimics an intravitreal injection without penetrating the eye.
  • Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4) (approximately 40 subjects). This study arm (which has the same route of administration and frequency as the test arm).

There is a 6-month, single-arm, open-label period after completion of the 6-month double-masked, controlled period.  This 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.

Inclusion Criteria:

  • 18 years or older. 
  • Non-Infectious Active Uveitis of the Posterior Segment.
Exclusion Criteria:
  • Confirmed or suspected infectious uveitis.
  • Females who are pregnant, nursing, or planning a pregnancy.

Contact:

Beachwood Office:  Dianne Himmelman   216-831-5700   •  dhimmelman@retina-assoc.com

To Learn More:  Go to  https://clinicaltrials.gov/ct2/show/NCT03711929