Ozurdex Monotherapy Trial (OM)
Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
About this trial
This is an interventional treatment trial for Uveitis, Posterior
Eligibility Criteria
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
Sites / Locations
- Ottawa Hospital Research Institute - Vision Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intravitreal Dexamethasone Implant Group
Prednisone Taper Group
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.
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.