Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Keratoconjunctivitis Sicca Resistant to Traditional Therapy in Patients With Chronic Ocular Graft-versus-host After Allogeneic Hematopoietic Stem Cell Transplantation.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Response of ocular chronic GVHD
研究概览
简要总结
The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. The corneal staining, conjunctival hyperemia, tear film break up time,Schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will be also assessed.
详细描述
The corneal staining with fluorescein will be assessed using Oxford grading scale.
Tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. Fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.Schirmer test will be performed without anesthesia. Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the impact of treatment on the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after allo-HSCT
- •Schirmer test < 5mm\5min
- •Tear Film Break-up Time < 5sec
- •Corneal staining > II Gr (Oxford grading scale)
- •Ocular Surface Disease Index (OSDI) >30
- •Resistance to conventional therapy
排除标准
- •Karnofsky <30%
- •Other concomitant conditions, which does not allow to adequately assess the condition of the eye surface;
- •Acute bacterial, viral or fungal infection of the eyes at the time of screening;
- •Somatic or mental pathology that does not allow you to sign an informed consent;
- •Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
研究组 & 干预措施
Allogeneic Platelet Lysate eye drops 50%
Patients with ocular chronic severe graft versus host disease receive 50% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day
干预措施: Allogeneic platelet lysate eye drops (Biological)
Allogeneic Platelet Lysate eye drops 20%
Patients with ocular chronic severe graft versus host disease receive 20% allogeneic Platelet Lysate in the form of eye drops 6-8 times a day
干预措施: Allogeneic platelet lysate eye drops (Biological)
结局指标
主要结局
Response of ocular chronic GVHD
时间窗: 2 years
Measured by 2015 NIH response criteria
次要结局
- Patient reported outcomes: severity of dry eye syndrome in patients with chronic ocular graft-versus-host and its impact on the quality of life based on 12 questions, score from 0 to 4.(2 years)
- Ocular adverse events(2 years)
- Tear film breakup time(2 years)
- Area of epithelial damage(2 years)
研究者
Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
St. Petersburg State Pavlov Medical University