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

Purpose

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.

Condition

  • Non Infectious Uveitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Test Arm: DE-109 Injectable Solution 		Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
  • Drug: DE-109 Intravitreal Injections
    440 ug of DE-109 Injectable Solution
Sham Comparator
Control Arm: 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.
  • Other: Sham Procedure
    The sham procedure mimics an intravitreal injection without penetrating the eye.
Other
Dummy Arm: DE-109 Injectable Solution 		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).
  • Drug: DE-109 Intravitreal Injections
    Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
Experimental
Open-label:DE-109 Injectable Solution 		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.
  • Drug: DE-109 Intravitreal Injections (Open Label)
    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)

More Details

Status
Terminated
Sponsor
Santen Inc.

Study Contact