Study Assessing Double-masked Uveitis Treatment (SAKURA)

June 21, 2019 updated by: Santen Inc.

A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

592

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, 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
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Golden, Colorado, 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
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Park, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Wichita, Kansas, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Cambridge, Massachusetts, United States
      • Peabody, Massachusetts, 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
    • Minnesota
      • Edina, Minnesota, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Missoula, Montana, United States
    • Nebraska
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
    • New Hampshire
      • Portsmouth, New Hampshire, 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
    • 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
    • North Carolina
      • Southern Pines, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oregon
      • Eugene, Oregon, 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
    • South Carolina
      • Columbia, South Carolina, United States
      • Ladson, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Knoxville, Tennessee, 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
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Ophthalmic solution low dose
Drug: DE-109 44 ug
Low dose
Other Names:
  • Sirolimus
ACTIVE_COMPARATOR: Ophthalmic solution medium dose
Drug: DE-109 440 ug
Medium dose
Other Names:
  • Sirolimus
ACTIVE_COMPARATOR: Ophthalmic solution high dose
Drug: DE-109 880 ug
High dose
Other Names:
  • Sirolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day1 (Baseline) and Month 5 (Day150)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day1/Baseline and Day150/Month 5
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)
Day1/Baseline and Day150/Month 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day1/Baseline and Day180/Month 6
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
Day1/Baseline and Day180/Month 6
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
Day1/Baseline and Day180/Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Investigators

  • Study Director: Abu Abraham, MD, Santen Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (ESTIMATE)

May 23, 2011

Study Record Updates

Last Update Posted (ACTUAL)

July 16, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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