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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
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.

Condition or disease Intervention/treatment Phase
Uveitis; Posterior, Disorder Drug: DE-109 Phase 3

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects with vitreous haze score [ Time Frame: 5 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


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Sponsors and Collaborators
Santen Inc.
Investigators
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Study Director: Abu Abraham, MD Santen Inc.
More Information
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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:
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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