Ozurdex as Monotherapy for Treatment of Non-infectious Intermediate, Posterior, or Panuveitis
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Percentage of patients with Vitreous Haze score of 0 at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Intravitreal Dexamethasone Implant Group
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.
干预措施: Ozurdex 0.7mg Ophthalmic Implant (Drug)
Prednisone Taper Group
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.
干预措施: Prednisone (Drug)
结局指标
主要结局
Percentage of patients with Vitreous Haze score of 0 at 6 months
时间窗: Measurements obtained 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.
次要结局
- 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)
- Change in central average volume (in mm3) from baseline to various time points(Measurements obtained at: 1 month, 2 months, 4 months, 6 months, 12 months)
- Incidence of complications(Anywhere between baseline to 12 months)
- Change in National Eye Institute Visual Function Questionnaire 25 Score(Baseline and 12mo)
- Percentage of patients with Vitreous Haze score of 0 at various time points(Measurements obtained at: 1 month, 2 months, 4 months, 6 months (primary outcome), 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)
- Best Corrected Visual Acuity at 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)
研究者
Chloe Gottlieb
Primary Co-Investigator
Ottawa Hospital Research Institute