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Study Assessing Double-masked Uveitis Treatment (SAKURA)

Primary Purpose

Uveitis; Posterior, Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DE-109 44 ug
DE-109 440 ug
DE-109 880 ug
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis; Posterior, Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Ophthalmic solution low dose

Ophthalmic solution medium dose

Ophthalmic solution high dose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)

Full Information

First Posted
May 19, 2011
Last Updated
June 21, 2019
Sponsor
Santen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01358266
Brief Title
Study Assessing Double-masked Uveitis Treatment
Acronym
SAKURA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis; Posterior, Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
592 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmic solution low dose
Arm Type
Active Comparator
Arm Title
Ophthalmic solution medium dose
Arm Type
Active Comparator
Arm Title
Ophthalmic solution high dose
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DE-109 44 ug
Other Intervention Name(s)
Sirolimus
Intervention Description
Low dose
Intervention Type
Drug
Intervention Name(s)
DE-109 440 ug
Other Intervention Name(s)
Sirolimus
Intervention Description
Medium dose
Intervention Type
Drug
Intervention Name(s)
DE-109 880 ug
Other Intervention Name(s)
Sirolimus
Intervention Description
High dose
Primary Outcome Measure Information:
Title
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
Description
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
Time Frame
Day1 (Baseline) and Month 5 (Day150)
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
Day1/Baseline and Day150/Month 5
Title
VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)
Description
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)
Time Frame
Day1/Baseline and Day150/Month 5
Other Pre-specified Outcome Measures:
Title
VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)
Description
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
Time Frame
Day1/Baseline and Day180/Month 6
Title
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)
Description
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
Time Frame
Day1/Baseline and Day180/Month 6
Title
VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)
Description
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
Time Frame
Day1/Baseline and Day180/Month 6

10. Eligibility

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

12. IPD Sharing Statement

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Study Assessing Double-masked Uveitis Treatment

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