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NCT03711929 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Santen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
NCT03711929: Clinical Trial Phase 3 study, sponsored by Santen.
NCT03711929 is a Phase 3 study that was terminated before completion, run by Santen. The registered enrollment target is 145 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03711929, a Phase 3 study, was terminated before completion, sponsored by Santen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
Study 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.
Primary Outcome
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 blurrin
Interventions
- OTHER Sham Procedure
- DRUG DE-109 Intravitreal Injections
- DRUG DE-109 Intravitreal Injections (Open Label)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2018-11-19 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 3 |
Why NCT03711929 stopped before completion
NCT03711929 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT03711929 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03711929 about?
NCT03711929 is a clinical study titled "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". 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 peri...
What is the current status of trial NCT03711929?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2018-11-19. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT03711929?
The interventions under investigation include: Sham Procedure (OTHER), DE-109 Intravitreal Injections (DRUG), DE-109 Intravitreal Injections (Open Label) (DRUG).
Who is sponsoring clinical trial NCT03711929?
This trial is sponsored by Santen, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03711929's enrollment target sits among peer trials
145 1555th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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