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

Phase 3

Terminated

Conditions: Non Infectious Uveitis

Interventions: Drug: DE-109 Intravitreal Injections (Open Label)
Drug: DE-109 Intravitreal Injections
Other: Sham Procedure

Registration Number: NCT03711929

Lead Sponsor: Santen Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 145

Inclusion Criteria

Non-Infectious Active Uveitis of the Posterior Segment

Exclusion Criteria

Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open-label:DE-109 Injectable Solution	DE-109 Intravitreal Injections (Open Label)	Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing.
Test Arm: DE-109 Injectable Solution	DE-109 Intravitreal Injections	Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
Control Arm: Sham Procedure	Sham Procedure	Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye.
Dummy Arm: DE-109 Injectable Solution	DE-109 Intravitreal Injections	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).

Primary Outcome Measures

Name	Time	Method
Vitreous Haze (VH) of Zero Response at Month 5	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

Secondary Outcome Measures

Name	Time	Method
Mean Composite Score at Month 3 and Month 5	Month 3, 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
Vitreous Haze (VH) of Zero Response at Month 3	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.

Trial Locations

Locations (65): 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
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Palo Alto, California, United States
California Eye Specialist Medical Group, Inc.
🇺🇸
Pasadena, California, United States
Colorado Retina Associates
🇺🇸
Golden, Colorado, United States
Retina Vitreous Associates of Florida
🇺🇸
Saint 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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Arizona Retina & Vitreous Consultants
🇺🇸Phoenix, Arizona, United States