A Phase 4 interventional study of Ozurdex 0.7mg Ophthalmic Implant and Prednisone in Uveitis, Posterior, Uveitis, Intermediate and Panuveitis, sponsored by Ottawa Hospital Research Institute. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Ottawa Hospital Research Institute · Phase 4, Interventional, and Treatment
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.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
Browse Uveitis, Posterior studies →Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to the experimental group will receive a 0.7mg intravitreal dexamethasone (DEX) implant which will be injected in the vitreous cavity as one of the treatments of interest in this study.
Drug: Ozurdex 0.7mg Ophthalmic Implant
Subjects randomized to the comparator group will receive oral prednisone. The initial dose is expected to range between 40 to 60mg of oral prednisone per day, with gradual tapering to the lowest dose that controls inflammation and eventually transitioning to a maintenance dose. Maintenance dose will be gradually lowered as per standard of care if remission is achieved for 6 to 12 months.
Drug: Prednisone
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.
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
Ran from Nov 2021 to primary completion in Jan 2025, 37 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dexamethasone Intravitreal Implant
Ottawa Hospital Research Institute →