Microfilarial Clearance From the Eye and Ocular Changes Associated With Ivermectin Treatment in Individuals With Onchocerciasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Number of participants with complete microfilaria clearance from the eye at 6 months
研究概览
简要总结
The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to determine the proportion of participants with complete Mf clearance from the eye at 3 and 6 months following treatment with ivermectin (IVM).
详细描述
This study will examine the kinetics of Mf clearance in the eye following ivermectin treatment. Previous studies have been unable to fully assess clearance Mf from the posterior chamber of the eye. This study will be the first to use optical coherence tomography (OCT) in patients with onchocerciasis to document parasites and pathology in the anterior and posterior chambers of the eye, and assess ocular changes following standard ivermectin treatment.
This will be a biomedical prospective cohort study.
The cohort will be stratified based on Mf levels to achieve approximately the following distribution of individuals with roughly one-third of participants in each group.
- Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in eyes using slit lamp and indirect ophthalmoscopy
- Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and 1-10 Mf in either eye at baseline (based on the highest number counted in either eye)
- Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and >10 Mf in either eye at baseline.
All participants recruited into the study will be treated with a single dose of ivermectin (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment with onchocerciasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have at least 1 palpable subcutaneous nodule (onchocercoma) and ≥ 1 Mf/mg of skin (by skin snip)
排除标准
- •Pregnancy and breastfeeding mothers within 1 month of giving birth
- •Have base line eye diseases including glaucoma, uveitis, severe keratitis, and/or cataracts that interfere with visualization of the posterior segment of the eye.
- •Prior allergic / hypersensitivity reactions or intolerance to ivermectin
- •Treatment with ivermectin in the past 6 (six) months
研究组 & 干预措施
Ivermectin
Single dose directly observed treatment with Ivermectin 3Mg Tab (150 ug/kg) delivered orally.
干预措施: Ivermectin 3Mg Tab (Drug)
结局指标
主要结局
Number of participants with complete microfilaria clearance from the eye at 6 months
时间窗: 6 months following treatment
Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye.
Number of participants with complete microfilaria clearance from the eye at 3 months
时间窗: 3 months following treatment
Microfilaria in the anterior chamber of the eye will be counted during slit lamp examination at time of assessment. Participants without Mf in the eye will be considered clear of infection in the eye.
次要结局
- The change from baseline in the number of microfilaria detected in the skin at 3 months(baseline, and 3 months following treatment)
- The change from baseline in the number of microfilaria detected in the eye at 3 months(baseline, 3 months following treatment)
- The change from baseline in the number of microfilaria detected in the skin at 6 months(baseline, and 6 months following treatment)
- The change from baseline in the number of microfilaria detected in the eye at 6 months(baseline, 6 months following treatment)
- Number of participants with complete microfilaria clearance from the skin at 3 months(3 months following treatment)
- Number of participants with complete microfilaria clearance from the skin at 6 months(6 months following treatment)