Study to Treat Uveitis Associated Macular Edema

Study Overview
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Brief Summary
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The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.

Detailed Description
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Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.

Official Title
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A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Uveitis Associated Macular Edema

Conditions
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Cystoid Macular Edema, Uveitis

Intervention / Treatment
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* Drug: denufosol tetrasodium (INS37217) Intravitreal Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye Have persistent macular edema and uveitis whose conditions are stable Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected) Have an OCT scan with a qualifying retinal thickness in the study eye Have evidence of macular edema on OCT scan Have at lease one eligible eye to be treated in the study based on visual acuity. Exclusion Criteria: Have proliferative vitreoretinopathy greater than grade B Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye Have ocular disorders in the study eye that may confound interpretation of study results Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening Have any ocular implant device for the delivery of therapeutic agents to the eye Be taking any excluded medications that could obscure or confound study results

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: denufosol tetrasodium (INS37217) Intravitreal Injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of denufosol in subjects presenting with uveitis associated macular edema. |  |  | 
| Assess the utility of denufosol in treating uveitis associated macular edema. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study - not specified |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uveitis, macular edema, uveitis associated macular edema