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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 is a Phase 3 study that was terminated before completion, run by Santen. The registered enrollment target is 145 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03711929
The ClinicalTrials.gov registry entry for NCT03711929 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Santen, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham Procedure is the first listed.
NCT03711929 reports 0 study locations.
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.
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