Study to Treat Uveitis Associated Macular Edema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-12-31

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.

Conditions

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Cystoid Macular Edema Uveitis

Keywords

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uveitis macular edema uveitis associated macular edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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denufosol tetrasodium (INS37217) Intravitreal Injection

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Schaberg, BSN

Role: STUDY_DIRECTOR

Countries

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United States

Other Identifiers

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06-103

Identifier Type: -

Identifier Source: org_study_id