Study Assessing Double-masked Uveitis Treatment (SAKURA)

Santen

Status and phase: Completed; Phase 3

Conditions: Uveitis; Posterior, Disorder

Treatments: Drug: DE-109 440 ug; Drug: DE-109 44 ug; Drug: DE-109 880 ug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358266

32-007

Details and patient eligibility

About

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

Enrollment: 592 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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592 participants in 3 patient groups

Ophthalmic solution low dose

Active Comparator group

Treatment:

Drug: DE-109 44 ug

Ophthalmic solution medium dose

Active Comparator group

Treatment:

Drug: DE-109 440 ug

Ophthalmic solution high dose

Active Comparator group

Treatment:

Drug: DE-109 880 ug