Study Assessing Double-masked Uveitis Treatment
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/30/2017 |
| Start Date: | May 2011 |
| End Date: | December 2016 |
A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections
of DE-109 ophthalmic solution.
of DE-109 ophthalmic solution.
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
We found this trial at
75
sites
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