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
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|ClinicalTrials.gov Identifier: NCT03711929|
Recruitment Status : Terminated (Business decision)
First Posted : October 19, 2018
Last Update Posted : November 10, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Non Infectious Uveitis||Drug: DE-109 Intravitreal Injections Other: Sham Procedure||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Actual Study Start Date :||November 19, 2018|
|Actual Primary Completion Date :||June 8, 2022|
|Actual Study Completion Date :||June 8, 2022|
Experimental: Test Arm: DE-109 Injectable Solution
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).
Drug: DE-109 Intravitreal Injections
440 ug of DE-109 Injectable Solution
Sham Comparator: Control Arm: Sham Procedure
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.
Other: Sham Procedure
The sham procedure mimics an intravitreal injection without penetrating the eye.
Dummy Arm: DE-109 Injectable Solution
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).
Drug: DE-109 Intravitreal Injections
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
- Vitreous Haze (VH) [ Time Frame: Month 5 ]VH of zero response at Month 5
- Vitreous Haze (VH) [ Time Frame: Month 3, Month 5 ]VH of zero or 2-unit response at Month 3 and 5
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Non-Infectious Active Uveitis of the Posterior Segment
Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711929
|Responsible Party:||Santen Inc.|
|Other Study ID Numbers:||
|First Posted:||October 19, 2018 Key Record Dates|
|Last Update Posted:||November 10, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|