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.
440 ug of DE-109 Injectable Solution
The sham procedure mimics an intravitreal injection without penetrating the eye.
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
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)
Lomas de Zamora, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires, Odisha, Argentina
Rosario, Santa Fe Province, Argentina
Caba, Argentina
Córdoba, Argentina