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Ozurdex Monotherapy Trial (OM)

Primary Purpose

Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Ozurdex 0.7mg Ophthalmic Implant
Prednisone
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis, Posterior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Intravitreal Dexamethasone Implant Group

Prednisone Taper Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Best Corrected Visual Acuity at various time points
This score will be used to determine the functional outcome (visual acuity) with the treatments.
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.
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.
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.
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
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
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.
Incidence of complications
Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis.
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.

Full Information

First Posted
October 11, 2021
Last Updated
December 14, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05101928
Brief Title
Ozurdex Monotherapy Trial
Acronym
OM
Official Title
Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Posterior, Uveitis, Intermediate, Panuveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Dexamethasone Implant Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Prednisone Taper Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ozurdex 0.7mg Ophthalmic Implant
Intervention Description
A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.
Primary Outcome Measure Information:
Title
Percentage of patients with Vitreous Haze score of 0 at 6 months
Description
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.
Time Frame
Measurements obtained at 6 months
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity at various time points
Description
This score will be used to determine the functional outcome (visual acuity) with the treatments.
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Proportion of patients with vitreous haze improvement by 1, and 2 units from baseline to various time points
Description
This score will be used to look at the degree of changes in the inflammation.
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Time to vitreous haze score of 0 from baseline to various time points
Description
This will be used to assess if there are differences in time to achieving lowest possible inflammation amongst groups.
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Anterior chamber cells/flare from baseline to various time points
Description
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.
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Change in central average thickness (µm) from baseline to various time points
Description
This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Change in central average volume (in mm3) from baseline to various time points
Description
This score will be used to assess anatomical changes (e.g. cystoid macular edema) with treatment
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months
Title
Change in National Eye Institute Visual Function Questionnaire 25 Score
Description
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.
Time Frame
Baseline and 12mo
Title
Incidence of complications
Description
Measure complication of treatment including but not limited to cataracts formation, ocular hypertension, vitreous hemorrhage, and endophthalmitis.
Time Frame
Anywhere between baseline to 12 months
Title
Percentage of patients with Vitreous Haze score of 0 at various time points
Description
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.
Time Frame
Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Lalonde, PhD
Phone
613-737-8159
Email
mlalonde@ohri.ca
Facility Information:
Facility Name
Ottawa Hospital Research Institute - Vision Research Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Lalonde
Phone
613-737-8519
Email
mlalonde@ohri.ca

12. IPD Sharing Statement

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Ozurdex Monotherapy Trial

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