Topical Infliximab for the Treatment of Sterile Corneal Melt
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Percentage of patients finishing 4 weeks of infliximab use
研究概览
简要总结
Corneal melt is a complication that could affect very ill eyes and lead to the thinning of the cornea (the clear window covering of the eyes). This thinning can lead to severe consequences such as the leakage of the liquid inside the eye (ocular perforation), or even blindness. Corneal melt can be caused by certain infections or as a sterile process. This project only includes patients with a sterile corneal melt (without an infection) caused by diseases such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.
Infliximab is an antibody against tumour necrosis factor alpha and has been used to treat or prevent corneal melt in certain patients with inflammatory of auto-immune disease. In this situation, infliximab was used intravenous (using veins) in order to treat the whole body.
This study's hypothesis is that infliximab can safely be used as eye drops for the treatment of sterile corneal melt.
详细描述
This is an unmasked, prospective, single-center trial of twelve patients with sterile corneal melt and an underlying auto-immune or inflammatory disease, such as rosacea, Sjogren's syndrome, rheumatoid arthritis, Crohn's disease, Stevens Johnson syndrome, as well as toxic epidermal necrolysis or mucous membrane pemphigoid.
The aim of this phase I study is to evaluate the safety and tolerability of topical infliximab 10mg/ml eye drops for the treatment of corneal melt. As such, six (6) subjects will be recruited in the experimental treatment study and six (6) subjects will be enrolled in the parallel observational study. Indeed, candidates having all inclusion criteria but one exclusion criteria (which are contraindication to infliximab use), will be recruited in the observational study, will receive the standard treatment without infliximab.
During the treatment period, subjects in the therapeutic study will receive topical infliximab 10mg/ml four (4) times per day for four (4) weeks. In order to determine the safety profile, potential side effects as well as the course of the disease, subjects will be monitored while on the study medication as well as for 8 weeks following discontinuation of the drug. The ophthalmological follow-up will be identical in the two groups. However, only subjects enrolled in the experimental treatment study will receive additional laboratory tests. The total study duration for each patient will be 12 weeks.
In terms of statistical analysis, the investigators will focus on describing the outcome measured in the study. For instance, the investigators will describe the number and proportion of side effects, the number of patients with a quiescent corneal melt at 4 weeks and the patients who required a tectonic surgery at 12 weeks post-treatment. The investigators will report the average and standard of deviation of the OSDI score, the epithelial deficit surface as well as the minimal corneal thickness. Moreover, the investigators will perform exploratory statistical analysis in order to study the disease course of each subject and comparing the addition of infliximab to the standard.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 80 years;
- •Any degree of active sterile corneal melting , as documented by slit-lamp examination, showing an epithelial defect and stromal thinning;
- •Negative work-up for local and systemic infectious causes
- •Negative corneal cultures (may show growth of common contaminants)
- •Capable of providing informed consent;
- •Capable of administering eye drops either themselves or through a caregiver.
排除标准
- •Any active ocular or systemic infection including active or latent tuberculosis, histoplasmosis, coccidiomycosis, cytomegalovirus, pneumocystosis, aspergillosis, or hepatitis B.
- •History of neoplasia diagnosed within the last 5 years
- •Demyelinating disease
- •Congestive heart failure
- •Significant anomalies on complete blood count, creatinine or hepatic enzymes
- •Pregnancy or breast feeding
- •Allergy to infliximab or to the drug vehicle (Refresh liquigel)
- •Past or present use of anti-TNF-α medications or human interleukin-1 receptor antagonist (anakinra, IL-1Ra)
研究组 & 干预措施
Observational group
Patients with all inclusive criteria and one exclusive criteria will receive the standard treatment, without topical infliximab.
Topical Infliximab
Additionally to standard treatment, patients with all inclusive criteria and none exclusive criteria will be included in the therapeutic group and will receive topical infliximab QID for 4 weeks.
干预措施: Topical Infliximab (Drug)
结局指标
主要结局
Percentage of patients finishing 4 weeks of infliximab use
时间窗: 4 weeks
Percentage of patients finishing 4 weeks of infliximab use
Adverse Events
时间窗: 12 weeks
Number and type of adverse events
次要结局
- Corneal thickness as measured by anterior segment optical coherence tomography(4 weeks)
- Visual Acuity(4 and 12 weeks)
- Conjunctival hyperemia using a slit-lamp photographs(4 and 12 weeks)
- Surface area of the corneal melt using a slit-lamp photographs(4 weeks)
- Ocular surface symptoms as assessed by ocular disease index score(4 and 12 weeks)
- Quiescent corneal state(4 weeks)
- Eyes requiring tectonic surgery(12 weeks)