clinical trial · 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
Non Infectious UveitisDE-109 Intravitreal InjectionsSham ProcedureDE-109 Intravitreal InjectionsDE-109 Intravitreal Injections (Open Label)
brief 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.
started
Nov 19, 2018
primary completion
Jun 14, 2022
completion
Jun 14, 2022
last updated
Dec 4, 2023
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol