Clinical trial NCT01358266: Study Assessing Double-masked Uveitis 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uveitis; Posterior, Disorder
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
timeFrame: Day1 (Baseline) and Month 5 (Day150)
Secondary outcomes:
measure: 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)
timeFrame: Day1/Baseline and Day150/Month 5
measure: VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)
timeFrame: Day1/Baseline and Day150/Month 5
Other outcomes:
measure: VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)
timeFrame: Day1/Baseline and Day180/Month 6
measure: 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)
timeFrame: Day1/Baseline and Day180/Month 6
measure: VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)
timeFrame: Day1/Baseline and Day180/Month 6
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Torrance
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Golden
country: United States
state: Colorado
city: Altamonte Springs
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Winter Haven
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Cambridge
country: United States
state: Massachusetts
city: Peabody
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Jackson
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Portsmouth
country: United States
state: New Hampshire
city: New Brunswick
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Northfield
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Slingerlands
country: United States
state: New York
city: Southern Pines
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Camp Hill
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Reading
country: United States
state: Pennsylvania
city: West Mifflin
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Ladson
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Florencio Varela
country: Argentina
city: Mendoza
country: Argentina
city: Olivos
country: Argentina
city: Pilar
country: Argentina
city: Rosario
country: Argentina
city: Graz
country: Austria
city: Klagenfurt
country: Austria
city: Americana
country: Brazil
city: Araraquara
country: Brazil
city: Londrina
country: Brazil
city: Recife
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Santiago
country: Chile
city: Bogota
country: Colombia
city: Cali
country: Colombia
city: Floridablanca
country: Colombia
city: Medellin
country: Colombia
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Heidelberg
country: Germany
city: Koln
country: Germany
city: Munchen
country: Germany
city: Munster
country: Germany
city: Tubingen
country: Germany
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Bhubaneshwar
country: India
city: Chennai
country: India
city: Hyderabad
country: India
city: Kolkata
country: India
city: Madurai
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Noida
country: India
city: Afula
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: 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
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Tokyo
country: Japan
city: Lima
country: Peru
city: Trujillo
country: Peru
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Wroclaw
country: Poland
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
city: 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
Study officials:
affiliation: Santen Inc.
name: Abu Abraham, MD
role: STUDY_DIRECTOR
References: