Study Assessing Double-masked Uveitis Treatment (SAKURA)
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ClinicalTrials.gov Identifier: NCT01358266 |
Recruitment Status :
Completed
First Posted : May 23, 2011
Last Update Posted : September 28, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Uveitis; Posterior, Disorder | Drug: DE-109 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 592 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ophthalmic solution low dose |
Drug: DE-109
Low dose
Other Name: Sirolimus |
Active Comparator: Ophthalmic solution medium dose |
Drug: DE-109
Medium dose
Other Name: Sirolimus |
Active Comparator: Ophthalmic solution high dose |
Drug: DE-109
High dose
Other Name: Sirolimus |
- Proportion of subjects with vitreous haze score [ Time Frame: 5 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of active uveitis
- 18 years of age or older
- Sign informed consent
- Meet best corrected ETDRS visual acuity
Exclusion Criteria:
- Uveitis of infectious etiology
- Suspected/confirmed central nervous system or ocular lymphoma
- Primary diagnosis of anterior uveitis
- Uncontrolled glaucoma
- Use of topical oculary medication
- Implanted device
- Significant ocular disease
- Lens/media opacities or obscured ocular media
- Intraocular surgery or treatments
- Capsulotomy
- Ocular or periocular infection
- Pupillary dilation
- History of herpetic infection
- Toxoplasmosis or toxoplasmosis scar
- Ocular malignancy
- Allergy or hypersensitivity to study drug
- Participation in other uveitis trial within 30 days
- Monoclonal antibody treatment or biologic therapy
- Any systemic condition/infection
- Immunosuppressive therapy or immunocompromised
- Malignancy remission
- Females who are pregnant or lactating and females not using adequate contraceptives

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358266

Study Director: | Abu Abraham, MD | Santen Inc. |
Responsible Party: | Santen Inc. |
ClinicalTrials.gov Identifier: | NCT01358266 History of Changes |
Other Study ID Numbers: |
32-007 |
First Posted: | May 23, 2011 Key Record Dates |
Last Update Posted: | September 28, 2017 |
Last Verified: | September 2017 |
Additional relevant MeSH terms:
Uveitis Uveal Diseases Eye Diseases Sirolimus Everolimus Ophthalmic Solutions Anti-Bacterial Agents Anti-Infective Agents |
Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmaceutical Solutions |