Ozurdex Monotherapy Trial
Key facts
- Who runs it
- Ottawa Hospital Research Institute
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Withdrawn
- Phase
- Phase 4
- Started
- 30 Nov 2021
- Ended
- 15 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ozurdex 0.7mg Ophthalmic Implant
- Prednisone
- Record updated
- 12 March 2025
- Why it stopped
- The study was withdrawn due to insufficient participant enrollment.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Intraocular surgery in the past 6 months
- 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
- Evidence of macular edema due to diabetes, retinal vein occlusion or any other ocular conditions
- Confirmed or suspected active ocular disease or infections
- History of glaucoma
- Presence of isolated anterior uveitis
- Intraocular pressure (IOP) of >21 mmHg at Screening/Baseline or confirmed normal-tension glaucoma
- For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Intravitreal Dexamethasone Implant GroupTreatment being tested
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.
Treatment: Ozurdex 0.7mg Ophthalmic Implant
- Prednisone Taper GroupExisting treatment, for comparison
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.
Treatment: Prednisone
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
- Record updated
- 12 March 2025