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SAKURA Study 1: Sirolimus in Active Non-Infectious Posterior Uveitis
NCT01358266Phase 3
Key facts
- Status
- Completed
- Start
- May 2011
- Primary completion
- Sep 2016
- Countries
- 17
- Sponsor
- Santen Pharmaceutical
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- non-infectious posterior uveitis (NIPU)
01
Overview
Phase 3, randomised, double-blind trial of sirolimus in non-infectious posterior uveitis (NIPU) (3 arms), sponsored by Santen Pharmaceutical. Primary endpoint: Vitreous Haze 0 Response at 5 months. Started May 2011; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Low Dose (44 ug)
DE-109 44 ug intravitreal injection (Active Control)
Medium Dose (440 ug)
DE-109 440 ug intravitreal injection
High Dose (880 ug)
DE-109 880 ug intravitreal injection
03
Who it enrols
Adult patients with confirmed active non-infectious uveitis of the posterior segment, excluding those with infectious etiology, glaucoma, or recent participation in other trials.
04
Endpoints
Primary
Vitreous Haze 0 Response
Secondary
Vitreous Haze 0 or 2-unit Improvement Response
Vitreous Haze 0 or 0.5+ Response
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