Ozurdex Monotherapy Trial (OM)

Ottawa Hospital Research Institute

Status and phase: Withdrawn; Phase 4

Conditions: Uveitis, Intermediate; Uveitis, Posterior; Panuveitis

Treatments: Drug: Prednisone; Drug: Ozurdex 0.7mg Ophthalmic Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05101928

CRRF ID 3008

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Intravitreal Dexamethasone Implant Group

Experimental group

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.

Treatment:

Drug: Ozurdex 0.7mg Ophthalmic Implant

Prednisone Taper Group

Active Comparator group

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.

Treatment:

Drug: Prednisone