A Prospective, Non-randomized, Non-controlled Trial: Initial Intravitreal Injection of High-dose Ganciclovir for Cytomegalovirus Retinitis in HIV-negative Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 主要终点
- CMV-DNA load in aqueous humor
研究概览
简要总结
This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.
详细描述
Cytomegalovirus retinitis (CMVR) is a serious vision-threatening disease. Intravitreal antiviral drug delivery was used as first-line treatment in several studies when systematic injection has been ruled out. The reported dose of intravitreal injections of ganciclovir (IVG) varied from 200 μg/0.1 ml to 5mg/0.1 ml in patients with AIDS. There was no consensus on the dose of ganciclovir in the treatment of CMVR in HIV-negative patients. Previous work showed the safety and the efficacy of 1mg IVG. The investigators proposed that a higher dose of ganciclovir (6mg/0.1ml) for the first injection followed by lower dose for maintenance may indicate a better result. Therefore, this study was performed to evaluate the therapeutic effect and safety of initial high-dose IVG for CMVR in HIV-negative patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CMVR by ophthalmological examination
- •Positive CMV-DNA in aqueous humor approved by real-time PCR.
- •HIV-negative.
排除标准
- •Diabetic retinopathy,
- •Glaucoma.
- •Optic neuritis.
研究组 & 干预措施
High dose of ganciclovir group
IVG was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor.
干预措施: Ganciclovir (Drug)
结局指标
主要结局
CMV-DNA load in aqueous humor
时间窗: Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.
The load of CMV-DNA level in aqueous humor was detected by means of real-time polymerase chain reaction (PCR). The aqueous humor was obtained before the IVG.
次要结局
- Visual function(Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.)
- Occurrence of IVG-related complications(Once a week. From the date of the first IVG until the date in which the CMV-DNA load turned undectable, assessed up to 10 weeks.)