Study Assessing Double-masked Uveitis Treatment

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Treatments: Everolimus; Ophthalmic Solutions; Sirolimus

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