Safety and Efficacy of Autologous Platelet Rich Plasma and Platelet Poor Plasma Eye Drops in the Treatment of Ocular Graft-Versus-Host Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of ocular graft versus host disease (O-GVHD). In addition to their current medication (except autologous serum drops), patients will receive PRP and PPP drops.
详细描述
Ocular involvement can be quite symptomatic in patients with chronic graft-versus-host disease (GVHD). The impact of ocular GVHD on quality of life (QOL) in patients with chronic GVHD has been studied in a prospective, multicenter, longitudinal, observational study and showed that ocular GVHD affects 57% of patients within 2 years of chronic GVHD diagnosis. Strong evidence suggested that ocular GVHD is associated with worse overall health-related QOL. Significant worsening of vision-related QOL in ocular GVHD has been reported. Ocular GVHD is devastating and there is no effective treatment available so far. The importance of this study is that for the first time in the nation, our institute will evaluate the safety and efficacy of topical autologous blood product (PRP and PPP) to treat ocular surface disease associated with ocular GVHD.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Willing and able to provide written informed consent.
- •Willing and able to comply with study assessments for the full duration of the study.
- •Diagnosis of ocular GVHD.
- •Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
- •In good stable overall health.
排除标准
- •Remission from primary cancer in more than 5 years.
- •History of thrombocytopenia (platelet<50,000) in the last 2 weeks before study entry.
- •Ocular or periocular malignancy.
- •Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
- •Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
- •Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
- •Current use of topical steroids more than twice a day.
- •Change in frequency of topical cyclosporine and/or topical kineret within the last month.
- •Signs of current infection, including fever and current treatment with antibiotics.
- •Intra-ocular surgery or ocular laser surgery within the last 3 months.
- •Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
- •Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
研究组 & 干预措施
PRP and PPP
PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.
干预措施: PRP eye drops (Biological)
PRP and PPP
PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.
干预措施: PPP eye drops (Biological)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: 8 Weeks
Safety and tolerability of topical autologous PRP and PPP four times a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the autologous blood products. The severity of each adverse event and relation to the study medication will be graded possibly, probably, or definitely related. Tolerability measures will be graded from trace to severe using a direct query method at each visit.
次要结局
- Efficacy of topical autologous PRP and PPP as measured by the National Eye Institute (NEI) grading scale(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT)(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by Schirmer Test I(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by Ocular Surface Disease Index (OSDI) questionnaire(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using flow cytometry (FC)(8 weeks)
- Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using real-time polymerase chain reaction (RT-PCR)(8 weeks)
研究者
Ladan Espandar
Assisant Professor
University of Pittsburgh