Study Assessing Double-masked Uveitis Treatment

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

Official Title
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A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye

Conditions
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Uveitis; Posterior, Disorder

Intervention / Treatment
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* Drug: DE-109 44 ug
* Drug: DE-109 440 ug
* Drug: DE-109 880 ug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ophthalmic solution low dose<br> | Drug: DE-109 44 ug<br>* Low dose<br>* Other names: Sirolimus;|
| Active Comparator: Ophthalmic solution medium dose<br> | Drug: DE-109 440 ug<br>* Medium dose<br>* Other names: Sirolimus;|
| Active Comparator: Ophthalmic solution high dose<br> | Drug: DE-109 880 ug<br>* High dose<br>* Other names: Sirolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5 | 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 | Day1 (Baseline) and Month 5 (Day150) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+ Moderate blurring of the optic nerve head Marked blurring of the optic nerve head Optic Nerve head not visible | 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) | 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 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex) | Day1/Baseline and Day150/Month 5 |