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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
145
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)
Arizona Retina & Vitreous Consultants
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Kaiser Permanente Medical Center
Los Angeles, California, United States
USC Roski Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
Vitreous Haze (VH) of Zero Response at Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Time frame: Month 5
Mean Composite Score at Month 3 and Month 5
Composite score scale is defined as follows. Each study eye was assigned one of the following scores: * Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit. * Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit. * Score = 0 if otherwise
Time frame: Month 3, Month 5
Vitreous Haze (VH) of Zero Response at Month 3
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.
Time frame: Month 3
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California Eye Specialist Medical Group, Inc.
Pasadena, California, United States
Colorado Retina Associates
Golden, Colorado, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
University of South Florida Eye Institute
Tampa, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
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