A Clinical Trial of Infliximab for Injection in Refractory Childhood Uveitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 10
- 主要终点
- Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
研究概览
简要总结
This project is designed to test the hypothesis that infliximab is clinically useful for patients with refractory childhood uveitis.
详细描述
Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All patients were provided with written informed consent and received a thorough explanation of the study design, aims, and the off-label use of infliximab, its potential risks and benefits. This is a prospective non-comparative interventional study.
Participants will receive intravitreal injections of suggested dose of infliximab (5 mg/kg/dose) and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 10 months to determine efficacy and side effects, and an additional 30 days for safety reports. Descriptive statistics will be gathered on participant demographics, uveitis characteristics, change in immunosuppressive medications, number of responders, ophthalmologic measures and change in corticosteroid dose during the study period.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 4 to 18 years old,
- •Non-infectious uveitis
- •Persistent uveitis uncontrolled by topical medications, or unacceptable side effects of topical medications.
- •Failure of at least six weeks of treatment with a non-biological disease modifying agent such as methotrexate, cyclosporine, mycophenolate mofetil, or azathioprine.
- •Ability to provide informed consent (subject or parent/guardian)
- •Onset of uveitis < 16 years of age.
- •Topical ophthalmologic treatments allowed.
- •Systemic corticosteroid use at entry may be allowed.
- •Participant must be able to cooperate for a non-sedated slit lamp exam and visual acuity examination.
- •Negative Purified Protein Derivative (PPD) placed and read within 1 month of initiation of infliximab
- •The screening laboratory test results must meet the following criteria:
- •WBC (white blood cell count): within normal range for institution ANC (absolute neutrophil count): within normal range for institution Hemoglobin: greater than 10 grams/deciliter Platelets: within normal range for institution Serum Creatinine: within normal range for age AST - aspartate aminotransferase - within normal range for institution ALT - alanine aminotransferase- within normal range for institution
排除标准
- •Previous use of biologic medications for uveitis.
- •Intraocular steroid injection or ophthalmologic surgery within the preceding 3 months.
- •Uveitis due to trauma or intraocular surgery
- •A history of a known allergy to murine products.
- •Documentation of seropositivity for human immunodeficiency virus (HIV).
- •Documentation of a positive test for hepatitis B surface antigen or hepatitis C
- •A known history of a serious infection (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
- •An opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- •A concomitant diagnosis or history of congestive heart failure.
- •A history of lymphoproliferative disease.
- •Any known malignancy or a history of malignancy.
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
- •Use of any investigational drug within 30 days prior to screening or within five half-lives of the first dose of the investigational agent, whichever is longer.
- •Presence of a transplanted solid organ.
研究组 & 干预措施
Patients with Childhood Uveitis
5mg/kg/dose of infliximab IV initially two weeks, then 4 weeks and then every 6-8 weeks
干预措施: infliximab (Drug)
结局指标
主要结局
Change In LogMAR Best Corrected Visual Acuity (BCVA) From Baseline to Each Visit.
时间窗: 24 weeks
Participant's best corrected visual acuity was measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 - 0.1; higher values indicate visual impairment.
次要结局
- Change in Anterior Chamber (AC) Cell Grade From Baseline to Each Visit.(24 weeks)
- Change in Vitreous Haze (VH) Grade From Baseline to Each Visit.(24 weeks)
研究者
Xiaomin Zhang
Principal Investigator, MD, PhD
Tianjin Medical University