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Corticosteroid

DE-109 Sirolimus for Posterior Uveitis (SPRING Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up by month12
Awards & highlights

Summary

The objective of this extension study is to evaluate the long-term safety of treatment with DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye who have participated in the SAKURA development program.

Eligible Conditions
  • Posterior Uveitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by month12
This trial's timeline: 3 weeks for screening, Varies for treatment, and by month12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Eye
Changes From Baseline in Vitreous Haze (VH) Scores at Month 12
Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye
+5 more

Side effects data

From 2017 Phase 3 trial • 60 Patients • NCT02251938
13%
Uveitis
12%
Intraocular Pressure Increased
10%
Intermediate Uvei
10%
Cystoid Macular Oedema
5%
Intraocular Pressure Decreased
5%
Iridocyclitis
5%
Sinusitis
5%
Macular Fibrosis
2%
Vitreous Hemorrhage
2%
Cerebrovascular Accident
2%
Cellulitis Gangrenous
2%
Cataract
2%
Trigeminal Neuralgia
2%
Visual Acuity Reduced
2%
Lung Adenocarcinoma Metastatic
2%
Pathological Fracture
2%
Arterial Occlusive Disease
2%
Procedural Complication
100%
80%
60%
40%
20%
0%
Study treatment Arm
DE-109 440 μg

Trial Design

1Treatment groups
Experimental Treatment
Group I: DE-109 SirolimusExperimental Treatment1 Intervention
DE-109 440 μg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor
34 Previous Clinical Trials
4,509 Total Patients Enrolled
Lanita Scott, MDStudy DirectorSanten Inc.
~5 spots leftby Sep 2025
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