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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.

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 44 ug Drug: DE-109 440 ug Drug: DE-109 880 ug 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 of the Posterior Segment of the Eye
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 44 ug
Low dose
Other Name: Sirolimus
Active Comparator: Ophthalmic solution medium dose Drug: DE-109 440 ug
Medium dose
Other Name: Sirolimus
Active Comparator: Ophthalmic solution high dose Drug: DE-109 880 ug
High dose
Other Name: Sirolimus


Outcome Measures
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Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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)


Other Outcome Measures:
  1. 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


  2. 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

  3. 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


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
Results First Posted: July 16, 2019
Last Update Posted: July 16, 2019
Last Verified: June 2019
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