Uveitis, PosteriorPhase 4OMNCT05101928
Ozurdex Monotherapy Trial
A Phase 4 study testing Ozurdex 0.7mg Ophthalmic Implant and Prednisone in people with Uveitis, Posterior and Uveitis, Intermediate, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- What is being tested?
- Ozurdex 0.7mg Ophthalmic Implant and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2021to 15 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Ottawa Hospital Research Institute - Vision Research Centre
Ottawa, Ontario, K1H8L6
About this study
Official title: Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
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.
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- Being tested
- Ozurdex 0.7mg Ophthalmic Implant, Prednisone
- Medical subject headings
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozurdex 0.7mg Ophthalmic ImplantDrug
A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.
PrednisoneDrug
The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Dexamethasone Implant Group | Experimental | 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. Receives: Drug: Ozurdex 0.7mg Ophthalmic Implant |
| Prednisone Taper Group | Active comparator | 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. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements obtained at 6 months
Secondary outcomes (9)
Best Corrected Visual Acuity at various time points
This score will be used to determine the functional outcome (visual acuity) with the treatments.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and 12mo
Incidence of complications
Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis.
Measured: 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.
Measured: Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start30 Nov 2021
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Why it stopped: The study was withdrawn due to insufficient participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chloe Gottlieb, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101928
- Sponsor's protocol ID
- CRRF ID 3008
- Acronym
- OM
- Status last verified
- Mar 2025
- First submitted
- 11 Oct 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
- ClinicalTrials.gov ID
- NCT05101928
- Acronym / sponsor ID
- OM / CRRF ID 3008
- Conditions
- Uveitis, Posterior, Uveitis, Intermediate, Panuveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to insufficient participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal Dexamethasone Implant Group | Experimental | Drug: Ozurdex 0.7mg Ophthalmic ImplantSubjects 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. |
| Prednisone Taper Group | Active comparator | Drug: PrednisoneSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozurdex 0.7mg Ophthalmic ImplantA 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months. | Drug | Intravitreal Dexamethasone Implant Group |
| PrednisoneThe comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus. | Drug | Prednisone Taper Group |
Primary outcome
Percentage of patients with Vitreous Haze score of 0 at 6 months
Time frame: 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.
9 secondary outcomes
Best Corrected Visual Acuity at various time points
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
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
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
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
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
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
Time frame: Baseline and 12mo
Incidence of complications
Time frame: Anywhere between baseline to 12 months
Percentage of patients with Vitreous Haze score of 0 at various time points
Time frame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex 0.7mg Ophthalmic Implant and Prednisone in people with Uveitis, Posterior and Uveitis, Intermediate, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with Vitreous Haze score of 0 at 6 months (time frame: Measurements obtained at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 30 Oct 2026.