Clinical Trials Logo
  1. Home
  2. Uveitis, Posterior
  3. NCT05101928

Ozurdex Monotherapy Trial — OM  

Uveitis, Posterior Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05101928
Study type Interventional
Source Ottawa Hospital Research Institute
Contact Miriam Muir, RN
Phone 613-737-8519
Email mmuir@ohri.ca
Status Recruiting
Phase Phase 4
Start date November 30, 2021
Completion date September 30, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT00570479 - Prophylactic Anecortave Acetate in Patients With a Retisert Implant Phase 1
Recruiting NCT05486468 - The Use of Two YUTIQ Versus Sham for Treatment of Chronic Non Infectious Intraocular Inflammation Affecting the Posterior Segment Phase 3
Terminated NCT03656692 - Safety and Effectiveness of Acthar Gel for Inflammation of the Eye's Uvea (Middle Layer) Phase 4
Completed NCT02255032 - Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis Phase 2
Completed NCT00035906 - Research Study in Patients With Persistent Macular Edema Phase 2
Terminated NCT05070728 - Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (FAI) Phase 3
Completed NCT02595398 - Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis Phase 3
Recruiting NCT03066869 - Efficacy and Safety of H.P. ACTHAR GEL in Adults With Retinal Vasculitis Phase 4
Completed NCT01539577 - A Long-Term Safety Study of OZURDEX® in Clinical Practice N/A
Recruiting NCT05322070 - Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis Phase 4
Recruiting NCT06085079 - Ixekizumab for the Management of Refractory Non-Infectious Uveitis: A Proof-of-Concept Study Phase 4
Completed NCT03145025 - Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Withdrawn NCT01905124 - Safety &Efficacy of CF101 to Subjects With Uveitis Phase 2
Completed NCT03598452 - High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients N/A
Completed NCT02049476 - Study of the Effectiveness of Ozurdex for the Control of Uveitis Phase 4
Completed NCT00404612 - A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Phase 3
Completed NCT00404742 - A Study of LX211 in Clinically Quiescent Non-infectious Intermediate, Anterior and Intermediate, Posterior or Pan-Uveitis Phase 3
Completed NCT02952001 - MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
Not yet recruiting NCT06431373 - A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis Phase 3
Completed NCT03097315 - Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis Phase 3