Study to Treat Uveitis Associated Macular Edema

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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