Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Adverse Events
研究概览
简要总结
This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.
详细描述
This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema.
Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior)
- •ETDRS BCVA score of ≥ 5 letters read in the study eye
排除标准
- •Any active ocular disease or infection in the study eye other than uveitis
- •Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications.
- •Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
- •Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
研究组 & 干预措施
4 mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 μL) of CLS-TA
干预措施: 4 mg CLS-TA Suprachoriodal Injection (Drug)
结局指标
主要结局
Adverse Events
时间窗: Baseline to 24 weeks
Number of patients with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). An adverse event (AE) is the development of an undesirable medical condition or the deterioration of a preexisting medical condition after or during exposure to a pharmaceutical product, whether or not considered causally related to the product. A TEAE is an AE occurring on or after the date of the first dose of study drug or worsening relative to the pre-treatment state. An SAE is an AE that fulfils one or more of the following: results in death; is immediately life-threatening; requires hospitalization nor prolongation of hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event that may jeopardize the subject or may require medical intervention to present one of the outcomes listed above.
次要结局
- Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye(Baseline, 24 Weeks)
- Mean Intraocular Pressure in the Study Eye(Baseline, 24 Weeks)
- Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye(Baseline, 24 Weeks)
- Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye(Baseline, 24 Weeks)