Clinical Trial to Evaluate Short-term Safety of Subconjunctival Adalimumab in Combination With Type 1 Boston Keratoprosthesis Implantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Evaluation of Treatment Related Adverse Events.
研究概览
简要总结
This trial is studying the safety and tolerability of receiving an injection of adalimumab (Humira) during the Boston Keratoprosthesis (KPro) surgery.
详细描述
This is a Phase I, Open-label, IND trial for participants undergoing a Boston Keratoprosthesis (KPro) procedure, to receive an injection of adalimumab (Humira), to study the safety and tolerability as well, to study whether there is a decrease to post surgical complications, and symptoms that participants would experience, if they did not receive the injection.
The study will recruit eight (8) participants, who will be monitored for thirty (30) days after the surgery, through eye examination and eye photos.
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 or older
- •Individuals eligible for keratoprosthesis surgery, as determined by standard-of-care eligibility criteria
- •Patients with poor prognosis for corneal transplantation, severe corneal opacity and/or vascularization
- •Patients with vision worse than 20/200 in the eligible eye, and contralateral eye with vision less than 20/40
- •Patients with intact nasal light projection
- •Willing and able to comply with study plan for the full duration of the study
- •Willing and able to sign a written informed consent
排除标准
- •Active tuberculosis or untreated latent tuberculosis (e.g., positive interferon-# release assay [IGRA] test, such as Quantiferon-gold)
- •Untreated active hepatitis B or C infection.
- •Ocular or periocular malignancy and/or infection
- •Inability to wear contact lens
- •Pregnancy (positive pregnancy test) or lactating
- •Participation in another interventional study at the time of screening
- •Any of the following baseline lab values
- •White blood count <3500 cells per microliter
- •Platelets <100,000 per microliter
- •Hematocrit <30%
- •AST or ALT >1.5X upper limit normal value
- •Multiple sclerosis or other demyelinating disease
- •Severe uncontrolled infection
- •Moderate to severe heart failure (NYHA class III/IV)
- •Active malignancy
- •History of adalimumab intolerance
- •Pregnancy or lactation
- •Medical problems or drug or alcohol dependence problems sufficient to prevent adherence to treatment and study procedures.
- •As judged by the investigator any patients that are questionable for their suitability in the study
研究组 & 干预措施
Adalimumab (Humira)
This arm will receive the study intervention.
干预措施: Adalimumab Injection (Drug)
结局指标
主要结局
Evaluation of Treatment Related Adverse Events.
时间窗: 30 Days
To evaluate safety following subconjunctival injection of adalimumab at the time of keratoprosthesis surgery in patients who have corneal problems of such severity that they require keratoprosthesis implantation. The incidence, severity, and duration of adverse events will be assessed and documented. Because the subjects in this study have corneal problems of such severity that they require keratoprosthesis implantation, special attention will be given to adverse events of particular concern, such as microbial keratitis, subconjunctival hemorrhage, subconjunctival inflammation, or retinal necrosis or retinal detachment
次要结局
- Efficacy of adalimumab Injection though changes in visual acuity.(30 Days)
- Efficacy of adalimumab Injection though changes in Optic Nerve Cup-to-Disk Ratio(Every Two (2) Weeks After Implantation/Injection until Day 30)
- Efficacy of adalimumab Injection through incidences of Intraocular Inflammation(30 Days)
- Efficacy of adalimumab Injection through changes in the Ocular Coherence Tomography (OCT) of the Optic Nerves(30 Days)
- Efficacy of adalimumab Injection though changes in the ocular coherence tomography (OCT) of the Retina(30 Days)
研究者
Thomas H. Dohlman, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary