Ozurdex Monotherapy Trial (OM)

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.

Study Overview

• Status: Withdrawn
• Conditions: Panuveitis; Uveitis, Posterior; Uveitis, Intermediate
• Intervention / Treatment: Drug: Ozurdex 0.7mg Ophthalmic Implant; Drug: Prednisone

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • Ottawa Hospital Research Institute - Vision Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravitreal Dexamethasone Implant 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.	Drug: Ozurdex 0.7mg Ophthalmic Implant; A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.
Active Comparator: Prednisone Taper Group; 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; The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements obtained at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity at various time points	This score will be used to determine the functional outcome (visual acuity) with the treatments.	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.	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.	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.	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	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	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.	Baseline and 12mo
Incidence of complications	Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis.	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.	Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Choroiditis; Choroid Diseases; Uveitis; Uveitis, Posterior; Uveitis, Intermediate; Pars Planitis; Panuveitis; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: CRRF ID 3008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes