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mTOR inhibitor

DE-109 Intravitreal Injections for Non-infectious Uveitis

Phase 3
Waitlist Available
Research Sponsored by Santen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-Infectious Active Uveitis of the Posterior Segment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 5
Awards & highlights

Study Summary

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

Eligible Conditions
  • Non-infectious Uveitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vitreous Haze (VH) of Zero Response at Month 5
Secondary outcome measures
Mean Composite Score at Month 3 and Month 5
Vitreous Haze (VH) of Zero Response at Month 3

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Test Arm: DE-109 Injectable SolutionExperimental Treatment1 Intervention
Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4).
Group II: Open-label:DE-109 Injectable SolutionExperimental Treatment1 Intervention
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.
Group III: Dummy Arm: DE-109 Injectable SolutionExperimental Treatment1 Intervention
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).
Group IV: Control Arm: Sham ProcedurePlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor
34 Previous Clinical Trials
4,424 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03711929.
~23 spots leftby Apr 2025
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