Topical IL-1-Ra for Treatment of Corneal Neovascularization
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Extent of Neovascular Area (NA)
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.
详细描述
Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Patients with superficial or deep corneal NV that extends farther than 1 mm from the limbus
- •Patients are in generally good stable overall health
排除标准
- •Has received treatment with anti-VEGF agents (topical, intraocular or systemic) within 30 days of study entry
- •Corneal or ocular surface infection within 30 days prior to study entry• Ocular or periocular malignancy
- •Contact lens (excluding bandage contact lens) use within 2 weeks prior to study entry
- •Persistent epithelial defect (>1mm and ≥14 days duration) within 2 weeks prior to study entry
- •Intravitreal or periocular steroids within 2 weeks prior to study entry
- •Change in dose/frequency of topical steroids and/or NSAIDs within 2 weeks prior to study entry
- •Pregnancy (positive pregnancy test) or lactation
- •Premenopausal women not using contraception
- •Signs of current infection, including fever and current treatment with antibiotics
- •Participation in another simultaneous medical investigation or trial
研究组 & 干预措施
Placebo first, then IL-1RA
It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
干预措施: Placebo (Drug)
Placebo first, then IL-1RA
It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.
干预措施: IL-1Ra (Drug)
IL-1RA first, then Placebo
It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
干预措施: Placebo (Drug)
IL-1RA first, then Placebo
It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
干预措施: IL-1Ra (Drug)
结局指标
主要结局
Extent of Neovascular Area (NA)
时间窗: 64 weeks
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Invasion Area (IA), Measuring the Fraction of the Total Corneal Area Invaded by the Vessels
时间窗: 64 Weeks
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
Incidence and Severity of Ocular Adverse Event
时间窗: 64 Weeks
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing.
Vessel Caliber (VC), Measuring the Mean Diameter of the Corneal Vessels
时间窗: 64 Weeks
The Principal Investigator decided to terminate the study and stop enrollment because of difficulty recruiting subjects. Although data were collected for this Outcome Measure, no analysis was performed. All records were destroyed following the required retention period. Data are no longer available for analysis.
次要结局
- Best Spectacle-Corrected Visual Acuity (BSCVA)(64 weeks)
- Central Corneal Thickness(64 Weeks)
研究者
Reza Dana, MD
Principal Investigator
Massachusetts Eye and Ear Infirmary