The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant. Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
0.59 mg Fluocinolone Acetonide implant
Duke University Eye Center
Durham, North Carolina, United States
Number of Eyes With Inflammation Recurrence
Number of eyes with inflammation recurrence
Time frame: 5 years
Percentage of Eyes With Improvement in Visual Acuity
Visual acuity was improved by two or more lines from baseline.
Time frame: baseline to 52 weeks
Number of Participant's Eye Requiring Adjunctive Therapy
Adjunctive Therapy needed to control inflammation in the implanted eye
Time frame: 5 years
Number of Eyes With Increased Intraocular Pressure
Time frame: 52 weeks
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