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Eligibility
for people ages 7 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

Cystoid macular edema is a condition in which there is swelling in the macula, the part of the retina that gives you your best vision. This swelling can cause your vision to get bad. When it is diagnosed early and treated, you vision usually can be preserved. However, if the swelling goes untreated for several months, it can cause permanent vision loss. We think that the two eyedrop regimens in this study, difluprednate or nepafenac plus prednisolone, might be effective in treating uveitic macular edema. Patients who enter this study are being randomized to one of the two regimens and are being followed for one month.

Official Title

Difluprednate Versus Nepafenac Plus Prednisolone Acetate for the Treatment of Cystoid Macular Edema Associated With Uveitis

Details

Randomized, observer-masked superiority trial of difluprednate 0.05% versus nepafenac 0.1% plus prednisolone acetate 1%.

Patients will be randomized at enrollment to either difluprednate 0.05% 6 times a day or prednisolone acetate 1% 6 times a day plus nepafenac 0.1% 3 times a day for 1 month. They will undergo repeat examination at 2 weeks post-enrollment (range 12 to 16 days) and at 4 weeks post-enrollment (range 25-35 days). The OCT, visual acuity and intraocular pressure examiner will be masked as to the patient's assignment. The treating physician and patient will be unmasked.

Keywords

Uveitis Cystoid Macular Edema Prednisolone acetate Methylprednisolone acetate Nepafenac Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Fluprednisolone Prednisolone hemisuccinate Prednisolone phosphate Difluprednate Ophthalmic Solutions

Eligibility

You can join if…

Open to people ages 7 years and up

  • cystoid macular edema secondary to anterior, intermediate, posterior or pan uveitis

You CAN'T join if...

  • Patients taking more than 10mg of oral prednisone a day
  • Patient has undergone Retisert placement within the past 3 years
  • Patient has undergone intravitreal or peribulbar injection of steroid within the past 3 months
  • Patient has undergone Ozurdex injection within the past 3 months
  • Patients with posterior uveitis and active inflammation
  • Patients who are pregnant, planning on becoming pregnant during the study period or who are breastfeeding.
  • Patients who are taking difluprednate or nepafenac at the beginning of the study
  • Patients with infectious uveitis who are not being treated for the infectious cause
  • Patients with advanced glaucoma or a cup-to-disc ratio of 0.9 or greater who do not have a functioning glaucoma surgery
  • Patients with infectious uveitis who are not receiving treatment for the infection or who have not already been treated.
  • Patients who have media opacities that prevent optical coherence tomography imaging.
  • Patients with an allergy to any of the components of the drugs used in this study.
  • Uncontrolled inflammation in patients with pan or posterior uveitis

Location

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT01939691
Phase
Phase 4
Lead Scientist
Nisha Acharya
Study Type
Interventional
Last Updated
December 2015
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