Study to Treat Uveitis Associated Macular Edema

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 2

Conditions

Uveitis

Cystoid Macular Edema

Treatments

Drug: denufosol tetrasodium (INS37217) Intravitreal Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00114062

06-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No 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