Panuveitis, Uveitis, Intermediate, Uveitis, Posterior
Conditions
Brief summary
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.
Interventions
DRUGPrednisone
The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.
DRUGOzurdex 0.7mg Ophthalmic Implant
A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Diagnosis of non-infectious intermediate, posterior, or panuveitis in at least one eye * Active uveitic disease at Screening/Baseline defined by the presence of at least 1 of the following parameters: 1) Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion 2) ≥ 1+ vitreous haze (NEI/SUN criteria)
Exclusion criteria
* Presence of isolated anterior uveitis * Evidence of macular edema due to diabetes, retinal vein occlusion or any other ocular conditions * Confirmed or suspected active ocular disease or infections * Intraocular surgery in the past 6 months * History of glaucoma * Intraocular pressure (IOP) of \>21 mmHg at Screening/Baseline or confirmed normal-tension glaucoma * Intravitreal or periocular injection within 6 months prior to screening. * Unable to tolerate systemic corticosteroids * Prior topical corticosteroid within 1 month of screening * Prior non-steroidal anti-inflammatory, systemic steroids, or immunomodulatory therapy (e.g. methotrexate) within 1 month of screening * For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with Vitreous Haze score of 0 at 6 months | Measurements obtained 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with vitreous haze improvement by 1, and 2 units from baseline to various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | This score will be used to look at the degree of changes in the inflammation. |
| Time to vitreous haze score of 0 from baseline to various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | This will be used to assess if there are differences in time to achieving lowest possible inflammation amongst groups. |
| Anterior chamber cells/flare from baseline to various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | 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. |
| Change in central average thickness (µm) from baseline to various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment |
| Best Corrected Visual Acuity at various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | This score will be used to determine the functional outcome (visual acuity) with the treatments. |
| Change in National Eye Institute Visual Function Questionnaire 25 Score | Baseline and 12mo | 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. |
| Incidence of complications | Anywhere between baseline to 12 months | Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis. |
| Percentage of patients with Vitreous Haze score of 0 at various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 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. |
| Change in central average volume (in mm3) from baseline to various time points | Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months | This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment |
Countries
Canada
Outcome results
None listed