NCT01358266
Completed
Phase 3
A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
ConditionsUveitis; Posterior, Disorder
Overview
- Phase
- Phase 3
- Intervention
- DE-109 44 ug
- Conditions
- Uveitis; Posterior, Disorder
- Sponsor
- Santen Inc.
- Enrollment
- 592
- Primary Endpoint
- The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.
Investigators
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
Arms & Interventions
Ophthalmic solution low dose
Intervention: DE-109 44 ug
Ophthalmic solution medium dose
Intervention: DE-109 440 ug
Ophthalmic solution high dose
Intervention: DE-109 880 ug
Outcomes
Primary Outcomes
The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5
Time Frame: Day1 (Baseline) and Month 5 (Day150)
At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0 = No inflammation
Secondary Outcomes
- 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)(Day1/Baseline and Day150/Month 5)
- VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)(Day1/Baseline and Day150/Month 5)
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