Macular Edema Nepafenac vs. Difluprednate Uveitis Trial

• Status: Terminated
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

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 decline. When diagnosed early and treated, you vision usually can be preserved. However, if the swelling goes untreated for a long time, it can cause permanent vision loss.

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Aravind Eye Hospitals, India
• Treatments: Difluprednate; Fluprednisolone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Nepafenac; Ophthalmic Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

108 patients with uveitic ME will be enrolled at Aravind Eye Hospital in Madurai, India based on the following eligibility criteria:

Patient-level Inclusion criteria:

• ≥18 years of age

• Diagnosis of anterior, intermediate, posterior, or panuveitis (can be infectious or non-infectious)

• Inactive or minimally active inflammation according to Standardization of Uveitis Nomenclature criteria (≤ 0.5+ Anterior Chamber (AC) cells, ≤ 0.5+ vitreous haze and no active retinal/choroidal lesions)

• If on oral corticosteroids, a stable dose of <10 mg prednisone/day for >4 weeks

• If on systemic corticosteroid-sparing immunomodulatory therapy, a stable dose for >4 weeks

• If using prednisolone acetate 1% drops, stable regimen of ≤2 drops per day for >4 weeks

• If infectious uveitis, inflammation must be inactive or minimally active per definition above and on stable dose of treatment for ≥4 weeks with no anticipated changes to treatment during the trial

Eye-level Inclusion Criteria

• ME defined as thickening of the 1mm central subfield of the macula greater than 2 standard deviations above normal thickness (>320 µm by Heidelberg spectral-domain OCT) with or without the presence of intraretinal cysts.

• Baseline intraocular pressure >5 mmHg and <21 mmHg (current use ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable)

• Media clarity and pupillary dilation sufficient to allow OCT testing and retinal photography

• Best-corrected visual acuity of 5/200 or better

Patient-level Exclusion Criteria

• Use of oral acetazolamide or other systemic carbonic anhydrase inhibitors at baseline

• Known allergy or hypersensitivity to any component of the study drugs

• Women who are pregnant or breastfeeding (pregnancy test should be administered prior to baseline fluorescein angiogram)

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

• History of central serous chorioretinopathy in either eye

Eye-level Exclusion Criteria

• Intravitreal or periocular corticosteroid injection in the past 8 weeks, dexamethasone implant in the past 12 months, or a fluocinolone acetonide implant in the past 3 years

• Presence of an epiretinal membrane-noted clinically or by OCT-in the study eye, thought to be significant enough to preclude improvement of ME

• Previous pars plana vitrectomy

• History of severe glaucoma (C/D ratio > 0.9 or any notching of optic nerve to rim)

• Prior use of difluprednate or nepafenac in the past 4 weeks