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Completed

NCT Number: NCT01358266

Study Assessing Double-masked Uveitis Treatment

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

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Key information

Conditions

Uveitis; Posterior, Disorder Eye Diseases Uveal Diseases Uveitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DE-109 44 ug

Drug

Low dose

Other names: Sirolimus

DE-109 440 ug

Drug

Medium dose

Other names: Sirolimus

DE-109 880 ug

Drug

High dose

Other names: Sirolimus

Primary outcomes

  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 outcomes

  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)

    • 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+
    • Moderate blurring of the optic nerve head
    • Marked blurring of the optic nerve head
    • 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 outcomes

  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)

    • 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+
    • Moderate blurring of the optic nerve head
    • Marked blurring of the optic nerve head
    • 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)

    • 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+
    • Moderate blurring of the optic nerve head
    • Marked blurring of the optic nerve head
    • Optic Nerve head not visible

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Registry information

Official study 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

Acronym: SAKURA

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 23, 2011
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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