Clinical trial NCT05101928: Ozurdex Monotherapy Trial
Official title: Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Uveitis, Posterior
Uveitis, Intermediate
Panuveitis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of patients with Vitreous Haze score of 0 at 6 months
timeFrame: Measurements obtained at 6 months
Secondary outcomes:
measure: Best Corrected Visual Acuity at various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Proportion of patients with vitreous haze improvement by 1, and 2 units from baseline to various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Time to vitreous haze score of 0 from baseline to various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Anterior chamber cells/flare from baseline to various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Change in central average thickness (µm) from baseline to various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Change in central average volume (in mm3) from baseline to various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
measure: Change in National Eye Institute Visual Function Questionnaire 25 Score
timeFrame: Baseline and 12mo
measure: Incidence of complications
timeFrame: Anywhere between baseline to 12 months
measure: Percentage of patients with Vitreous Haze score of 0 at various time points
timeFrame: Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute - Vision Research Centre
state: Ontario
Study officials:
References: