This study will investigate the efficacy and safety of OZURDEX® (dexamethasone intravitreal implants; DEX, Allergan, Inc. Irvine, CA) as monotherapy for the treatment of non-infectious intermediate-, posterior- or panuveitis. This is a prospective randomized controlled clinical trial taking place at the University of Ottawa Eye Institute, Ottawa, Ontario, Canada, and other possible centers in Canada. Consecutive consenting subjects who meet inclusion/exclusion criteria will be selected to participate in this study. The subjects must have either non-infectious intermediate, posterior, or panuveitis. The subjects will be randomly chosen to be part of one of two groups; one group will receive DEX as monotherapy and the other group will receive oral prednisone. Approximately 84 eyes (42 per arm) will take part in study. The primary outcome will measure the proportion of eyes with a vitreous haze score of 0 six months post initial treatment. Secondary measures will include best corrected visual acuity (BCVA), central retinal thickness (CRT) measured by spectral-domain optical coherence tomography (SD-OCT), time to vitreous haze resolution and time to failure defined at number of months with DEX implant until an adjunct therapy is indicated. Baseline measurements will be recorded within 1 month prior to treatment in both groups, with follow up measurements collected at 0, 1, 2, 4, 6 and 12 months post-operatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.
The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.
Ottawa Hospital Research Institute - Vision Research Centre
Ottawa, Ontario, Canada
Percentage of patients with Vitreous Haze score of 0 at 6 months
This score (using NEI/SUN criteria) is used to grade intraocular inflammation based on vitreous cells and protein exudation. A lower score is indicative of less inflammation which is the goal when using either Ozurdex implant or a oral prednisone.
Time frame: Measurements obtained at 6 months
Best Corrected Visual Acuity at various time points
This score will be used to determine the functional outcome (visual acuity) with the treatments.
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Proportion of patients with vitreous haze improvement by 1, and 2 units from baseline to various time points
This score will be used to look at the degree of changes in the inflammation.
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Time to vitreous haze score of 0 from baseline to various time points
This will be used to assess if there are differences in time to achieving lowest possible inflammation amongst groups.
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Anterior chamber cells/flare from baseline to various time points
Using SUN grading criteria, the proportion of patients with cells grade 0, 0.5+, 1+, 2+, 3+, 4+ and flare grade of 0, 1+, 2+, 3+, 4+ will be determined at Month 6.
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Change in central average thickness (µm) from baseline to various time points
This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Change in central average volume (in mm3) from baseline to various time points
This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Change in National Eye Institute Visual Function Questionnaire 25 Score
This will be used to determine impact of disease on the subject's quality of life. The worst possible score is 0 while best is 100. The higher the score, the higher the subjective visual function.
Time frame: Baseline and 12mo
Incidence of complications
Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis.
Time frame: Anywhere between baseline to 12 months
Percentage of patients with Vitreous Haze score of 0 at various time points
This score (using NEI/SUN criteria) is used to grade intraocular inflammation based on vitreous cells and protein exudation. A lower score is indicative of less inflammation which is the goal when using either Ozurdex implant or a oral prednisone.
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months
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