Ozurdex Monotherapy Trial
A legfontosabb adatok
- Ki végzi
- Ottawa Hospital Research Institute
- Hol
- Kanada1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Visszavonva
- Fázis
- 4. fázis
- Kezdés
- 2021. nov. 30.
- Befejezés
- 2025. jan. 15.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Ozurdex 0.7mg Ophthalmic Implant
- Prednisone
- A regiszteradat frissítve
- 2025. március 12.
- Miért állt le
- The study was withdrawn due to insufficient participant enrollment.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 14 feltétel megnézéseKevesebb
Ki vehet részt
- 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)
Ki nem vehet részt
- Intraocular surgery in the past 6 months
- 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
- Evidence of macular edema due to diabetes, retinal vein occlusion or any other ocular conditions
- Confirmed or suspected active ocular disease or infections
- History of glaucoma
- Presence of isolated anterior uveitis
- Intraocular pressure (IOP) of >21 mmHg at Screening/Baseline or confirmed normal-tension glaucoma
- For women: pregnant or breast feeding, or planning to become pregnant while enrolled in the study
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Intravitreal Dexamethasone Implant GroupA vizsgált kezelés
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.
Kezelés: Ozurdex 0.7mg Ophthalmic Implant
- Prednisone Taper GroupMár használt kezelés, összehasonlításként
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.
Kezelés: Prednisone
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
- A regiszteradat frissítve
- 2025. március 12.