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
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- STATUS
- Recruiting
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- End date
- Jun 30, 2022
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- participants needed
- 200
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- sponsor
- Santen Inc.
Summary
This is a Phase III study to assess the efficacy and safety of DE-109 440 g 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 doublemasked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 g every 2 months for longer duration than appropriate for a placebo or sham control.
Details
| Condition | Non Infectious Uveitis |
|---|---|
| Treatment | Sham Procedure, DE-109 Intravitreal Injections |
| Clinical Study Identifier | NCT03711929 |
| Sponsor | Santen Inc. |
| Last Modified on | 3 March 2021 |
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