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

Santen

Status and phase: Terminated; Phase 3

Conditions: Non Infectious Uveitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03711929

010906IN

Details and patient eligibility

About

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.

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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145 participants in 4 patient groups

Test Arm: DE-109 Injectable Solution

Experimental group

Description:

Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).

Treatment:

Drug: DE-109 Intravitreal Injections

Drug: DE-109 Intravitreal Injections

Control Arm: Sham Procedure

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Procedure

Dummy Arm: DE-109 Injectable Solution

Other group

Description:

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).

Treatment:

Drug: DE-109 Intravitreal Injections

Drug: DE-109 Intravitreal Injections

Open-label:DE-109 Injectable Solution

Experimental group

Description:

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.

Treatment:

Drug: DE-109 Intravitreal Injections (Open Label)