NCT03711929

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

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.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Infectious Uveitis

Interventions

Type	Name	Description
DRUG	DE-109 Intravitreal Injections	440 ug of DE-109 Injectable Solution
OTHER	Sham Procedure	The sham procedure mimics an intravitreal injection without penetrating the eye.
DRUG	DE-109 Intravitreal Injections	Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
DRUG	DE-109 Intravitreal Injections (Open Label)	After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)

Timeline

• Start date: 2018-11-19
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2018-10-19
• Last updated: 2023-12-04
• Results posted: 2023-12-04

Locations

65 sites across 4 countries: United States, Argentina, India, Italy

Regulatory

• FDA-regulated drug study