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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
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Santen Inc.

Tracking Information
First Submitted Date  ICMJE May 19, 2011
First Posted Date  ICMJE May 23, 2011
Results First Submitted Date  ICMJE May 8, 2018
Results First Posted Date  ICMJE July 16, 2019
Last Update Posted Date July 16, 2019
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: June 21, 2019)
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5 [ Time Frame: Day1 (Baseline) and Month 5 (Day150) ]
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2011)
Proportion of subjects with vitreous haze score [ Time Frame: 5 months ]
Change History Complete list of historical versions of study NCT01358266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2019)
  • VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale) [ Time Frame: Day1/Baseline and Day150/Month 5 ]
    At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
    1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
    2. Moderate blurring of the optic nerve head
    3. Marked blurring of the optic nerve head
    4. Optic Nerve head not visible
  • VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale) [ Time Frame: Day1/Baseline and Day150/Month 5 ]
    At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 21, 2019)
  • VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale) [ Time Frame: Day1/Baseline and Day180/Month 6 ]
    At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
  • VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale) [ Time Frame: Day1/Baseline and Day180/Month 6 ]
    At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
    1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
    2. Moderate blurring of the optic nerve head
    3. Marked blurring of the optic nerve head
    4. Optic Nerve head not visible
  • VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale) [ Time Frame: Day1/Baseline and Day180/Month 6 ]
    At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)
    1. Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+
    2. Moderate blurring of the optic nerve head
    3. Marked blurring of the optic nerve head
    4. Optic Nerve head not visible
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 of the Posterior Segment of the Eye
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 44 ug
    Low dose
    Other Name: Sirolimus
  • Drug: DE-109 440 ug
    Medium dose
    Other Name: Sirolimus
  • Drug: DE-109 880 ug
    High dose
    Other Name: Sirolimus
Study Arms  ICMJE
  • Active Comparator: Ophthalmic solution low dose
    Intervention: Drug: DE-109 44 ug
  • Active Comparator: Ophthalmic solution medium dose
    Intervention: Drug: DE-109 440 ug
  • Active Comparator: Ophthalmic solution high dose
    Intervention: Drug: DE-109 880 ug
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 June 2019

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