Uveitis; Posterior, DisorderPhase 3SAKURANCT01358266
Study Assessing Double-masked Uveitis Treatment
A Phase 3 study testing DE-109 44 ug, DE-109 440 ug and DE-109 880 ug in people with Uveitis; Posterior, Disorder, run by Santen Inc. at 151 sites in 17 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis; Posterior, Disorder
- What is being tested?
- DE-109 44 ug, DE-109 440 ug and DE-109 880 ug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 151 sitesin 17 countries
- Study dates
- May 2011to Dec 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of active uveitis
- 18 years of age or older
- Sign informed consent
- Meet best corrected ETDRS visual acuity
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
151 sites in 17 countries.
151 sites in 17 countries
United States74 sites
Study site
Albany, New York
Study site
Altamonte Springs, Florida
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Ann Arbor, Michigan
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Arlington, Texas
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Augusta, Georgia
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Aurora, Colorado
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Austin, Texas
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Baltimore, Maryland
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Beverly Hills, California
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Boston, Massachusetts
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Burlington, Vermont
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Cambridge, Massachusetts
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Camp Hill, Pennsylvania
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Chicago, Illinois
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbia, South Carolina
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Dallas, Texas
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Edina, Minnesota
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Eugene, Oregon
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Fort Worth, Texas
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Golden, Colorado
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Grand Rapids, Michigan
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Houston, Texas
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Indianapolis, Indiana
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Iowa City, Iowa
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Jackson, Michigan
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Jacksonville, Florida
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Knoxville, Tennessee
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Ladson, South Carolina
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Lincoln, Nebraska
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Loma Linda, California
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Los Angeles, California
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McAllen, Texas
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Miami, Florida
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Milwaukee, Wisconsin
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Missoula, Montana
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Mountain View, California
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New Brunswick, New Jersey
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New York, New York
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Newark, New Jersey
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Northfield, New Jersey
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Oak Park, Illinois
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Omaha, Nebraska
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Orchard Park, New York
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Orlando, Florida
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Peabody, Massachusetts
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Portsmouth, New Hampshire
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Rapid City, South Dakota
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Reading, Pennsylvania
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Richmond, Virginia
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Rochester, New York
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Royal Oak, Michigan
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Sacramento, California
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Salt Lake City, Utah
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San Antonio, Texas
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Slingerlands, New York
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Southern Pines, North Carolina
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Southfield, Michigan
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St Louis, Missouri
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Tampa, Florida
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Teaneck, New Jersey
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Toms River, New Jersey
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Torrance, California
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Tucson, Arizona
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Virginia Beach, Virginia
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West Mifflin, Pennsylvania
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Wichita, Kansas
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Winston-Salem, North Carolina
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Winter Haven, Florida
India10 sites
Study site
Ahmedabad
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Bangalore
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Bhubaneswar
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Chennai
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Hyderabad
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Kolkata
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Madurai
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Mumbai
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New Delhi
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Noida
Israel8 sites
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Afula
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Beersheba
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Haifa
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Jerusalem
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Petah Tikva
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Ramat Gan
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Rehovot
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Tel Aviv
Brazil7 sites
Study site
Americana
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Araraquara
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Londrina
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Recife
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Rio de Janeiro
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São Paulo
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Sorocaba
Germany7 sites
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Berlin
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Cologne
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Freiburg im Breisgau
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Heidelberg
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München
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Münster
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Tübingen
Argentina6 sites
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Buenos Aires
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Mendoza
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Olivos
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Pilar
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Rosario
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San Juan Bautista
Italy6 sites
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Bologna
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Florence
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Milan
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Padova
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Pisa
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Reggio Emilia
Japan5 sites
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Hokkaido
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Osaka
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Sapporo
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Sendai
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Tokyo
Spain5 sites
Study site
Alicante
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Barcelona
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Madrid
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Santiago de Compostela
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Torrevieja
Colombia4 sites
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Bogotá
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Cali
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Floridablanca
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Medellín
Poland4 sites
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Lodz
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Lublin
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Poznan
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Wroclaw
United Kingdom4 sites
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Belfast
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Bradford
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Bristol
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London
Turkey (Türkiye)3 sites
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Ankara
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Istanbul
Study site
Izmir
About this study
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
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
- Conditions
- Uveitis; Posterior, Disorder
- Being tested
- DE-109 44 ug, DE-109 440 ug, DE-109 880 ug
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-109 44 ugDrug
Also called Sirolimus
Low dose
DE-109 440 ugDrug
Also called Sirolimus
Medium dose
DE-109 880 ugDrug
Also called Sirolimus
High dose
| Study group | Role | What they receive |
|---|---|---|
| Ophthalmic solution low dose | Active comparator | Not described Receives: Drug: DE-109 44 ug |
| Ophthalmic solution medium dose | Active comparator | Not described Receives: Drug: DE-109 440 ug |
| Ophthalmic solution high dose | Active comparator | Not described Receives: Drug: DE-109 880 ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at 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 = No inflammation
Measured: Day1 (Baseline) and Month 5 (Day150)
Secondary outcomes (2)
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)
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
Measured: 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)
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)
Measured: Day1/Baseline and Day150/Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveitis; Posterior, DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abu Abraham, MD, Study director, Santen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358266
- Sponsor's protocol ID
- 32-007
- Acronym
- SAKURA
- Status last verified
- Jun 2019
- First submitted
- 19 May 2011
- Last updated
- 16 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01358266
- Acronym / sponsor ID
- SAKURA / 32-007
- Conditions
- Uveitis; Posterior, Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ophthalmic solution low dose | Active comparator | Drug: DE-109 44 ug |
| Ophthalmic solution medium dose | Active comparator | Drug: DE-109 440 ug |
| Ophthalmic solution high dose | Active comparator | Drug: DE-109 880 ug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of active uveitis
- 18 years of age or older
- Sign informed consent
- Meet best corrected ETDRS visual acuity
Key exclusion criteria (22 listed)
- Uveitis of infectious etiology
- Suspected/confirmed central nervous system or ocular lymphoma
- Primary diagnosis of anterior uveitis
- Uncontrolled glaucoma
- Use of topical oculary medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DE-109 44 ugAlso: SirolimusLow dose | Drug | Ophthalmic solution low dose |
| DE-109 440 ugAlso: SirolimusMedium dose | Drug | Ophthalmic solution medium dose |
| DE-109 880 ugAlso: SirolimusHigh dose | Drug | Ophthalmic solution high dose |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
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A Proof-of-concept Trial to EvaluAte the efficaCy and Safety Of Cell Therapy TRX103 in Patients With Active, Non-infectious Uveitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abu Abraham, MD study director
Santen Inc.
151 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DE-109 44 ug, DE-109 440 ug and DE-109 880 ug in people with Uveitis; Posterior, Disorder, run by Santen Inc. at 151 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 151 sites in United States, India, Israel, Brazil, Germany and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.