"In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device."
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Feasibility of using the collection device under testing
研究概览
简要总结
Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.
详细描述
Autologous Serum exhibits characteristics very similar to those of tears, such as pH, osmolarity, vitamins, and Immunoglobulin A. It also contains growth factors, nutritional factors, and antibacterial components that are necessary for the maintenance of cellular viability in the epithelial repair process. The use of autologous serum eye drops was first described in 1984 by Fox et al., in research for a preservative-free tear substitute. Subsequently, in 1999, Tsubota et al. found that, due to the presence of growth factors and vitamins, autologous serum could have a true epithelial trophic potential for the ocular surface. The autologous serum eye drops are not only a lubricant for the ocular surface but also provide various essential substances for the reconstruction of epithelial damage, including vitamin A, epithelial growth factor, fibronectin, and a variety of cytokines. With these epithelial trophic factors, autologous serum facilitates proliferation, migration, and differentiation of the ocular surface epithelium. Moreover, it is known for its anti-catabolic properties, inhibiting the inflammatory cascade triggered by interleukin-1, which prevents tissue destruction. Therefore, autologous serum eye drops have been effective in the treatment of persistent epithelial defects, neurotrophic ulcers, superior limbic keratoconjunctivitis, dry eye conditions, graft-versus-host disease (GVHD), or after refractive surgeries, such as LASIK (Laser Assisted In Situ Keratomileusis). In 2020, Wang et al. published an article with 7 randomized controlled trials comparing the use of autologous serum versus artificial tears in patients with dry eye syndrome. In the meta-analysis, all 7 studies evaluated subjective symptoms and showed that autologous serum eye drops were superior to ocular lubricants in alleviating and remitting symptoms. It was shown that autologous serum eye drops significantly improved parameters such as OSDI (Ocular Surface Disease Index), tear break-up time, and Bengal Rose staining when compared to the control group using ocular lubricants. Given the numerous properties of autologous serum eye drops, there is no doubt about their benefit and effectiveness in treating several ocular surface diseases, including ocular GVHD. However, the difficulty in accessing production and the substantial cost of autologous serum eye drops are the main challenges, and their use is often limited to more severe dry eye cases and those refractory to conventional treatment.
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
- •≥ 18 years
- •Dry eye and/or chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;
- •Peripheral venous access or PICC that allows the collection of whole blood.
排除标准
- •Active ocular infection;
- •Hemoglobin < 11 g/dL;
- •Angina, MI, or stroke in the last 30 days;
- •Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;
- •Active ocular or systemic infection at the time of collection;
- •Inability to attend follow-up visits at 6 and 12 weeks;
- •Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);
- •Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;
- •Life expectancy < 6 months;
- •Not pregnant (as reported by the participant).
研究组 & 干预措施
Production of autologous serum in a closed system for ocular use
干预措施: Autologous Serum 20% (Drug)
结局指标
主要结局
Feasibility of using the collection device under testing
时间窗: 2 years
Proportion of blood collections that resulted in successful production of final autologous serum containers suitable for patient use.
次要结局
- Global ocular symptom score(Baseline, 6 weeks, 12 weeks, and end of treatment)
- Corneal staining score (Rose Bengal)(Baseline, 6 weeks, 12 weeks)
- Meibography(Baseline, 6 weeks, 12 weeks)
- Tear film lipid layer(Baseline, 6 weeks, 12 weeks)
- Pre-freezing microbiological test of autologous serum(2 years)
- Median pre-freezing number of leukocytes in autologous serum(2 years)
- Median pre-freezing number of red blood cells in autologous serum(2 years)
- Median pre-freezing number of platelets in autologous serum(2 years)
- Median pre and post-freezing pH in autologous serum(2 years)
- NIH ocular score(baseline, 6 weeks, 12 weeks, and end of treatment)
- Ocular Surface Disease Index(Baseline, 6 weeks, 12 weeks, and end of treatment)
- Lee score ocular subscale(Baseline, 6 weeks, 12 weeks, and end of treatment)
- Schirmer test(Baseline, 6 weeks, 12 weeks)
- Team's qualitative perception of the feasibility of collection and production of autologous serum(At 50% of planned recruitment)
- Non-invasive tear film break-up(Baseline, 6 weeks, 12 weeks)
- Corneal staining score (fluorescein)(Baseline, 6 weeks, 12 weeks)
- Adherence to the use of autologous serum(At 6 and 12 weeks post-treatment)
- Patient's qualitative evaluation of the use of autologous serum(At 12 weeks post-treatment)
研究者
GIANCARLO FATOBENE
MD, PhD
University of Sao Paulo General Hospital