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Study Assessing Double-masked Uveitis Treatment (SAKURA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Last Update Posted Date September 28, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Proportion of subjects with vitreous haze score [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01358266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Assessing Double-masked Uveitis Treatment
Official Title  ICMJE A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis
Brief Summary The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Uveitis; Posterior, Disorder
Intervention  ICMJE
  • Drug: DE-109
    Low dose
    Other Name: Sirolimus
  • Drug: DE-109
    Medium dose
    Other Name: Sirolimus
  • Drug: DE-109
    High dose
    Other Name: Sirolimus
Study Arms  ICMJE
  • Active Comparator: Ophthalmic solution low dose
    Intervention: Drug: DE-109
  • Active Comparator: Ophthalmic solution medium dose
    Intervention: Drug: DE-109
  • Active Comparator: Ophthalmic solution high dose
    Intervention: Drug: DE-109
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2016)
592
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2011)
500
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   Chile,   Colombia,   France,   Germany,   India,   Israel,   Italy,   Japan,   Peru,   Poland,   Spain,   Turkey,   United Kingdom,   United States
Removed Location Countries Dominican Republic,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT01358266
Other Study ID Numbers  ICMJE 32-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Santen Inc.
Study Sponsor  ICMJE Santen Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Abu Abraham, MD Santen Inc.
PRS Account Santen Inc.
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP