A Clinical Study of High Concentration(2%) Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Fundus lesions
研究概览
简要总结
Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis
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 use of 2% Ganciclovir Eye Drops, its potential risks and benefits. This is a monocencer, single arm, prospective study. The experimental group is: 2% Ganciclovir Eye Drops therapy group.
Administration method and dose adjustment: 2% ganciclovir eye drops, 10 times / day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than six weeks.
According to best corrected visual acuity (BCVA), intraocular pressure, corneal abrasion, anterior chamber and vitreous inflammation, optical coherence tomography (OCT), Ultra wide angle fundus image and so on. The investigators evaluate the effects of 2% Ganciclovir Eye Drops in treatment of cytomegalovirus retinitis.
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
- 2 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily participate in studies and sign informed consent forms
- •Ages 2-80 years (with cut-off values) male and female
- •One of the following is true （1）In patients with cytomegalovirus retinitis after hematopoietic stem cell transplantation/cord blood transplantation, the white blood cell count is less than 4× 10^9/L, and the platelet count ranges are 25× 10^9/L≤ PLT<100×10^9/L，Intravitreal injection carries a greater risk of infection and bleeding, and is unable to administer systemic medication due to the bone marrow suppression of antiviral drugs, or systemic medication for severe CMV retinitis cannot be well controlled; （2）In patients with CMVR with AIDS, the CD4+ T cell count is less than 100/μl, there is a great risk of infection with intravitreal injection, and the systemic medication of severe CMV retinitis cannot be well controlled.
排除标准
- •Eye condition
- •The presence of refractive interstitial opacification affects fundus observation;
- •Intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline;
- •Other diseases that can affect visual function such as syphilis-related eye diseases, acute retinal necrosis, congenital glaucoma, congenital corneal lesions, congenital macular degeneration, etc.
- •General condition
- •Severe neutropenia (<0.5×10^9) or severe thrombocytopenia (< 25× 10^9/L);
- •Other investigators judged patients who were not suitable for enrollment;
研究组 & 干预措施
2% Ganciclovir Eye Drops therapy Group
Administration method and dosage adjustment: 2% ganciclovir eye drops, 10 times/day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than 6 weeks
干预措施: 2% Ganciclovir Eye Drops (Drug)
结局指标
主要结局
Fundus lesions
时间窗: 24 weeks
The size changes of fundus lesions after medication are recorded
次要结局
- Change In LogMAR Best Corrected Visual Acuity (BCVA)From Baseline to Each visit(24 weeks)
研究者
Xiaomin Zhang
Principal Investigator,MD,PhD
Tianjin Medical University