Ozurdex Monotherapy Trial

NCT05101928 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: CRRF ID 3008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Best Corrected Visual Acuity at various time points

  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

  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

  Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months

• Anterior chamber cells/flare from baseline to various time points

  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

  Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months

Study Arms (2)

Intravitreal Dexamethasone Implant Group

EXPERIMENTAL

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

Prednisone Taper Group

ACTIVE COMPARATOR

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

Interventions

Ozurdex 0.7mg Ophthalmic Implant DRUG

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

Intravitreal Dexamethasone Implant Group

Prednisone DRUG

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

Prednisone Taper Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute - Vision Research Centre

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Uveitis, Posterior; Uveitis, Intermediate; Panuveitis

Interventions

Calcium Dobesilate; Vision, Ocular; Prednisone

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Co-Investigator

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: November 1, 2021
• Study Start: November 30, 2021
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CA (1)