Study Assessing Double-masked Uveitis Treatment

Completed · Phase 3

Conditions studied: Uveitis; Posterior, Disorder

In brief

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

Key facts

Study ID

NCT01358266

Run by

Santen Inc.

People needed

592

Starts

2011-05-01

Expected to finish

2016-12-01

Last updated by the study team

2019-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of active uveitis
• 18 years of age or older
• Sign informed consent
• Meet best corrected ETDRS visual acuity

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mountain View, California, United States
• Study site — Sacramento, California, United States
• Study site — Torrance, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Golden, Colorado, United States
• Study site — Altamonte Springs, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Oak Park, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Wichita, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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