The purpose of this study is to determine the tolerability, safety, and benefits of an investigational drug,Fluocinolone Acetonide Intravitreal Insert (FA-i), in people who have posterior uveitis. The study drug, Fluocinolone Acetonide, is currently used in a surgical implant, Retisert, which is approved by the U.S. Food and Drug Administration (FDA) to treat non-infectious posterior uveitis . The study drug is able to be inserted in an ophthalmology (eye) clinic; whereas Retisert must be surgically implanted in the Operating Room. Initially, this was a 2-dose randomized pilot study. However, the study was modified to include only the 0.2 ug/day implant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Duke Eye Center
Durham, North Carolina, United States
Change in status of uveitis in study eye.
Anterior chamber cells will be measured using a Haag-Streit Slit Lamp at high magnification (1.6 X) x 1mm beam. Assessment will be made using the Standardization of Uveitis Nomenclature (SUN) scale. Ophthalmoscopy will be performed to assess vitreous haze, which will be graded according to the scale provided with photographs reproduced from Nussenblatt et al, (Ophthalmology 92:467-471, 1985).
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in IOP (intraocular pressure) in study eye.
Goldmann tonometry will be used to measure IOP.
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in lens status in study eye.
Lens changes will be assessed with a Haag-Streit Slit Lamp.
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in endophthalmitis in study eye.
The study eye will be evaluated for endophthalmitis by undergoing inspection with a Haag Streit Slit Lamp and an indirect ophthalmoscope.
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in vitreous status in study eye.
A Haag-Streit Slit Lamp and an indirect ophthalmoscope will be used to assess for any hemorrhaging in the study eye.
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in retinal status in study eye.
The retina will be evaluated using a Haag Streit Slit Lamp and an indirect ophthalmoscope.
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
Change in macular thickness in study eye.
Spectralis SD-OCT will be used to assess macular thickness.
Time frame: Assessed at Screening, Day 14, 28, Months 2, 3, 6, 9, 12, 15, 18, 21, and 24.
Change in Best Corrected Visual Acuity in the study eye.
The visual acuity is measured according to the standard procedure developed for the Early Treatment Diabetic Retinopathy Study (ETDRS) and adapted for the Age-Related Eye Disease Study (AREDS).
Time frame: Assessed at Screening, Day 0, Day 1, Day 14, Day 28, Months 2, 3, 4, 5, 6, 9, 12, 15, 18, 21, and 24.
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