Efficacy of Intravitreal Adalimumab Compared to Subcutaneous Adalimumab in Patients With Non-infectious Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Vitreous Haze
研究概览
简要总结
The objective of this study is to compare and evaluate the efficacy of subcutaneous (40mg) adalimumab biweekly injections to intravitreal adalimumab (1.5 mg/ 0.03 mL) administration, given at zero, 2 weeks then every four weeks, in subjects with active non-infectious intermediate-, posterior-, or pan-uveitis.
详细描述
Subject groups:
32 subjects will be enrolled in this study, 16 in each arm. They will be randomized to receive either 1.5 mg/ 0.03 mL of adalimumab by intravitreal injection or 40 mg of adalimumab subcutaneously at their first treatment visit and at the 2 weeks visit if eligible for a repeat injection. Follow up will be every 2 days the first week then one week later and after that every 4-week intervals for total of 26 weeks.
Intervention Details:
- Systemic adalimumab: Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.
- Local adalimumab: Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.
Pre-treatment work up
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
- Single (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
- •Subject is ≥ 18 years of age.
- •Subject is diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis.
- •Subject must have active disease at baseline as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of prednisone ≥ 10 mg/day (or oral corticosteroid equivalent):
- •Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
- •≥ 1+ anterior chamber cells (Standardization of Uveitis Nomenclature [SUN] criteria)
- •≥ 1+ vitreous haze (National Eye Institute [NEI]/SUN criteria)
- •Subject with documented prior adequate response to oral corticosteroids (equivalent of oral prednisone up to 1 mg/kg/day).
- •If subject is on prednisone >=10 mg (or corticosteroid equivalent) at baseline, the dose has not been increased or decreased in the past 14 days.
- •No increase in the immune modulatory therapy in the past three months
- •Negative PPD test.
- •Positive PPD test on anti Tb medications.
排除标准
- •Subject with isolated anterior uveitis.
- •Subject with confirmed or suspected infectious uveitis, including but not limited to infectious uveitis due to TB, cytomegalovirus, lyme disease, toxoplasmosis and herpes simplex virus (HSV).
- •Subject with serpiginous choroidopathy.
- •Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial.
- •Subject with corneal or lens opacities that preclude the evaluation of the vitreous haze.
- •Subject with uncontrolled high intraocular pressure of ≥ 25 mmHg on maximal therapy.
- •Subject with intermediate uveitis and symptoms and/or MRI findings suggestive of a demyelinating disease such as multiple sclerosis. All subjects with intermediate uveitis must have had a prior brain MRI at time of or after diagnosis of intermediate uveitis.
- •Subject has received glucocorticosteroids implant (Retisert®), or Ozurdex within 6 months prior to baseline visit.
- •Subject has received intraocular or periocular corticosteroids or intravitreal methotrexate within 90 days prior to Baseline visit.
- •Subject with proliferative or severe non-proliferative diabetic retinopathy.
- •Subject with neovascular/wet age-related macular degeneration
- •Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process.
- •Subject with a systemic inflammatory disease and requires additional therapy with a systemic immunosuppressive agent at the time of study entry.
- •Subjects with history of active or latent Mycobacterium tuberculosis documented by Purified Protein Derivative (PPD) and chest X-ray and not anti tuberculosis (TB) treatment.
研究组 & 干预措施
Intravitreal
Intravitreal injection of 1.5mg/0.03ml adalimumab given at zero, 2 weeks, and then every 4 weeks.
干预措施: Adalimumab (Drug)
Systemic
Subcutaneous injection of 40 mg adalimumab (Humira) given every 2 weeks.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Vitreous Haze
时间窗: 26 Weeks
Change in Vitreous Haze grade in each eye \[National Eye Institute (NEI)/ Standardization of Uveitis Nomenclature (SUN) criteria\]
Anterior Chamber Cells
时间窗: 26 Weeks
Change in Anterior Chamber (AC) cell grade in each eye.
次要结局
- Macular Edema(26 Weeks)
- Angiography Score(26 Weeks)
- Visual Acuity(26 Weeks)
- Steroids Tapering(26 Weeks)