A Clinical Trial of Oral Acyclovir in Viral Uveitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean and median change in best corrected visual acuity in logMAR
研究概览
简要总结
This project is designed to test the hypothesis that acyclovir is clinically useful for patients with refractory viral 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, benefits and potential risks. This is a prospective non-comparative interventional study.
Aqueous humor samples were collected from participants to virus detection. Participants will take oral acyclovir 100 mg three times a day and data will be collected prospectively with regard to ophthalmologic outcomes. Study participants will be followed for up to 12 months to determine efficacy, 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and above.
- •Chronic, vision threatening viral uveitis.
- •Patients can't tolerate hormone therapy bacause of drug side effects.
- •Consent to undergo anterior chamber tap and give aqueous for the study.
- •Able to undergo relevant tests.
- •Able to come for subsequent follow-up visits.
- •Ability to provide informed consent.
排除标准
- •Patients who are allergic to ayclovir.
- •Immunocompromised patients
- •Positive for HIV, Hep B and Hep C
- •Not keen on participating in the study
- •Patients who are incapable, either by law or mental state, of giving consents in their own right.
- •Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol.
- •Patients who are pregnant or breastfeeding.
- •Any other specified reason as determined by the clinical investigator.
研究组 & 干预措施
Patients with Viral Uveitis
Oral acyclovir 100 mg three times a day (TID).
干预措施: Acyclovir (Drug)
结局指标
主要结局
Mean and median change in best corrected visual acuity in logMAR
时间窗: 12 weeks
Mean and median change in best corrected visual acuity in logMAR
次要结局
- Number of participants who experience a recurrence(12 weeks)
- Length of time to quiescence(12 weeks)
- Ability to taper concomitant immunosuppressive medications(12 weeks)
- Number and severity of systemic and ocular toxicities and adverse events(12 weeks)
研究者
Xiaomin Zhang
MD, PhD, Principal Investigator, Clinical Professor
Tianjin Medical University