NCT05101928

Ozurdex Monotherapy Trial

Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Prednisone	The comparator will be a prednisone taper which is currently the standard care for the uveitis types of focus.

Timeline

• Start date: 2021-11-30
• Primary completion: 2025-01-15
• Completion: 2025-01-15
• First posted: 2021-11-01
• Last updated: 2025-03-12

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study