Study to Treat Uveitis Associated Macular Edema

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Terminated

CT.gov ID

NCT00114062

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cystoid Macular Edema Uveitis	Drug: denufosol tetrasodium (INS37217) Intravitreal Injection	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

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

Pilot study - not specified []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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