Ozurdex Monotherapy Trial

NCT ID: NCT05101928

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2025-01-15

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.

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ozurdex 0.7mg Ophthalmic Implant

Intervention Type: DRUG

A 0.7mg intravitreal dexamethasone implant will be used for the treatment of posterior, intermediate and panuveitis for minimum of 6 months.

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.

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.

Interventions

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.

Intervention Type: DRUG

Prednisone

The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Chloe Gottlieb

Primary Co-Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ottawa Hospital Research Institute - Vision Research Centre

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

CRRF ID 3008

Identifier Type: -

Identifier Source: org_study_id