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About
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.
Full description
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) combination therapy of prednisolone acetate 1% with nepafenac 0.1% 3) combination therapy of difluprednate 0.05% with nepafenac 0.1%
Masking: Unmasked treatment administration; masked outcome assessment (evaluation of OCT and visual acuity)
Follow-up: 2, 4, 6, 8, and 24 weeks
Treatment protocol:
Patients will be randomized at enrollment to either:
If macular edema has not resolved at Week 4, continue study treatment at the same dose until Week 6.
If macular edema has resolved at Week 4, reduce study treatment as follows:
If macular edema does not resolve at Week 4 but has resolved at Week 6, reduce study treatment at Week 6 as follows:
After Week 8, there are no restrictions on the treatments patients may receive, and medications can be tapered further, discontinued, or changed at the discretion of the treating physician and patient preference. If a patient with previously resolved macular edema has a recurrence, the physician may treat according to best medical judgement.
Enrollment
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Inclusion and exclusion 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:
Eye-level Inclusion Criteria
Patient-level Exclusion Criteria
Eye-level Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
9 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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