NCT03298815已完成1 期
A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.
详细描述
This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and are diagnosed with Chronic Graft Verses Host Disease of the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms:
- •Dry eye symptoms partially affecting (requiring lubricant drops > 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
- •Unable to work because of ocular symptoms
- •Loss of vision due to keratoconjunctivitis sicca (KCS)
- •Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- •Patients who are 18 years of age or older.
- •Willing and able to provide informed consent.
排除标准
- •Patients who have any other reversible cause for dry eye at the time of accrual.
- •More than 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
- •Relapsed malignancy at time of accrual after the most recent transplantation
- •A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report
- •Patients who are pregnant or plan to become pregnant while participating in the study.
- •Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF.
- •Inability to comply with the investigational plan and visit schedule for any reason, in the judgement of the investigator.
研究组 & 干预措施
Amniotic Fluid Eye Drops (AFED) - All participants, One eye
Active Comparator
干预措施: Amniotic Fluid Eye Drops (AFED) (Biological)
Saline Solution - All participants, One eye
Placebo Comparator
干预措施: Saline Solution (Other)
结局指标
主要结局
Overall Response Rate
时间窗: 30 days
Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.
次要结局
- Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days(baseline and 100 days)
- Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days(baseline and 30 days)
- Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 60 Days(baseline and 60 days)
- Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 100 Days(baseline and 100 days)
- Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline to 30 Days(baseline and 30 days)
- Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 60 Days(baseline and 60 days)
- Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 100 Days(baseline and 100 days)
- Change in Pain Assessment From Baseline to 60 Days(baseline and 60 days)
- Changes in Visual Acuity(baseline, 30 days, 60 days, and 100 days)
- Effects on the Corneal Surface(Up to 100 days)
- Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days(baseline and 30 days)
- Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days(baseline and 60 days)
研究者
研究点 (1)
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