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

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

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

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


Locations
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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Beverly Hills, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Sacramento, California, United States
Torrance, California, United States
United States, Colorado
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
United States, Florida
Altamonte Springs, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Oak Park, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Kansas
Wichita, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Peabody, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Jackson, Michigan, United States
Royal Oak, Michigan, United States
Southfield, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Montana
Missoula, Montana, United States
United States, Nebraska
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
United States, New Hampshire
Portsmouth, New Hampshire, United States
United States, New Jersey
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
Northfield, New Jersey, United States
Teaneck, New Jersey, United States
Toms River, New Jersey, United States
United States, New York
Albany, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Slingerlands, New York, United States
United States, North Carolina
Southern Pines, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Eugene, Oregon, United States
United States, Pennsylvania
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
West Mifflin, Pennsylvania, United States
United States, South Carolina
Columbia, South Carolina, United States
Ladson, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Burlington, Vermont, United States
United States, Virginia
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Argentina
Buenos Aires, Argentina
Florencio Varela, Argentina
Mendoza, Argentina
Olivos, Argentina
Pilar, Argentina
Rosario, Argentina
Austria
Graz, Austria
Klagenfurt, Austria
Brazil
Americana, Brazil
Araraquara, Brazil
Londrina, Brazil
Recife, Brazil
Rio de Janeiro, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Chile
Santiago, Chile
Colombia
Bogota, Colombia
Cali, Colombia
Floridablanca, Colombia
Medellin, Colombia
France
Marseille, France
Nantes, France
Paris, France
Germany
Berlin, Germany
Freiburg, Germany
Heidelberg, Germany
Koln, Germany
Munchen, Germany
Munster, Germany
Tubingen, Germany
India
Ahmedabad, India
Bangalore, India
Bhubaneshwar, India
Chennai, India
Hyderabad, India
Kolkata, India
Madurai, India
Mumbai, India
New Delhi, India
Noida, India
Israel
Afula, Israel
Beer Sheva, Israel
Haifa, Israel
Jerusalem, Israel
Petaẖ Tiqwa, Israel
Ramat Gan, Israel
Rehovot, Israel
Tel Aviv, Israel
Italy
Bologna, Italy
Firenze, Italy
Milano, Italy
Padova, Italy
Pisa, Italy
Reggio Emilia, Italy
Japan
Hokkaido, Japan
Osaka, Japan
Sapporo, Japan
Sendai, Japan
Tokyo, Japan
Peru
Lima, Peru
Trujillo, Peru
Poland
Lodz, Poland
Lublin, Poland
Poznan, Poland
Wroclaw, Poland
Spain
Alicante, Spain
Barcelona, Spain
Madrid, Spain
Santiago de Compostela, Spain
Torrevieja, Spain
Turkey
Ankara, Turkey
Istanbul, Turkey
Izmir, Turkey
United Kingdom
Belfast, United Kingdom
Bradford, United Kingdom
Bristol, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Santen Inc.
Investigators
Layout table for investigator information
Study Director: Abu Abraham, MD Santen Inc.

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Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01358266    
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