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Eligibility
for people ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

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 three eye drop regimens in this study, difluprednate, prednisolone acetate, or nepafenac plus prednisolone acetate, might be effective in treating uveitic macular edema. Patients who enter this study are being randomized to one of the three regimens and are being followed for 24 weeks.

Official Title

First-line Topical Treatments for Uveitic Macular Edema Trial

Details

Trial: Randomized 3 arm (1:1:1) parallel design comparative effectiveness trial

Stratification: Systemic corticosteroid/immunosuppressive therapy vs. none

Treatments: 1) difluprednate 0.05% 2) prednisolone acetate 1% and 3) combination therapy of nepafenac 0.1% with prednisolone acetate 1%

Masking: Unmasked treatment administration; masked outcome assessment (evaluation of OCT and visual acuity)

Follow-up: 2, 4, 8, 12, and 24 weeks

Treatment protocol:

  1. difluprednate 0.05% 4 times a day for a minimum of 2 weeks, then taper according to protocol (if resolution of edema at 2 weeks, start tapering by 1 drop every week; if not resolved, continue at 4 times a day until 4 weeks and then taper by 1 drop every week)
  2. prednisolone acetate 1% : 4 times a day for a minimum of 2 weeks, then taper according to protocol (if resolution of edema at 2 weeks, start tapering by 1 drop every week; if not resolved, continue at 4 times a day until 4 weeks and then taper by 1 drop every week)
  3. nepafenac 0.1% with prednisolone acetate 1%: nepafenac 3 times a day continue until resolution; prednisolone acetate 1% 4 times a day for a minimum of 2 weeks, then taper according to protocol (if resolution of edema at 2 weeks, start tapering by 1 drop every week; if not resolved, continue at 4 times a day until 4 weeks and then taper by 1 drop every weeks

Keywords

Uveitis Macular Edema difluprednate prednisolone acetate nepafenac Methylprednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Fluprednisolone Prednisolone hemisuccinate Prednisolone phosphate Ophthalmic Solutions

Eligibility

You can join if…

Open to people ages 18 years and up

Patients must have the following in at least one eye:

  • Thickening of the 1mm central subfield of the macula>320 µm as measured by Heidelberg spectral-domain optical coherence tomography (OCT) with or without the presence of intraretinal cysts.19
  • Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature criteria.20
  • Baseline intraocular pressure must be>5 mmHg and <21 mmHg in both eyes (current use≤2 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable).
  • Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography.

    If a patient is on oral corticosteroids or on corticosteroid-sparing immunosuppressive therapy, a stable dose of <10 mg prednisone/day and a stable regimen of the immunosuppressive drug for>4 weeks is required.

    If using prednisolone acetate 1% eye drops, stable regimen of <3 drops/day for at least 4 weeks.

You CAN'T join if...

Patients taking oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline and those whose systemic immunosuppressive drug therapy has not been stable for at least 4 weeks will be excluded.

No prior use of difluprednate or nepafenac in the past 4 weeks Patients whose systemic immunosuppressive drug therapy has not been stable for at least 4 weeks Patients who are pregnant, planning on becoming pregnant during the study period or who are breastfeeding.

Patients unwilling or unable to not wear contact lenses during the study period.

Eye level exclusion:

  • Corticosteroid injection in the past 3 months or a fluocinolone acetonide implant in the past 3 years.
  • Presence of an epiretinal membrane noted clinically or by OCT that is thought to be significant enough to preclude improvement of ME.

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
April 1, 2017
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