Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Neovascularization Area
研究概览
简要总结
Corneal stromal injection is an emerging local drug delivery method, characterized by strong targeting, high drug concentration, and prolonged duration of action. It has been preliminarily applied in the treatment of fungal keratitis and neurotrophic corneal diseases. This study aims to investigate the safety and efficacy of anti-VEGF drugs delivered via corneal stromal injection in neovascularization caused by HSK (Herpes Simplex Keratitis). The study has clear medical significance and technical feasibility, and it is expected to promote innovation in the treatment paradigm for corneal neovascularization.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis: Patients who meet the diagnostic criteria for Herpes Simplex Virus (HSV) keratitis with neovascularization.
- •Age: Adults aged 18 years or older.
- •Previous Treatment: Patients who have not undergone other anti-VEGF treatments or corneal surgeries.
- •Informed Consent: Patients who are capable of understanding and signing an informed consent form, agreeing to participate in the entire study process and to follow the study's follow-up schedule and treatment plan.
- •Other: Additional criteria as deemed necessary by the investigator.
排除标准
- •Risk of Corneal Perforation: Patients at risk of corneal perforation.
- •Severe Ocular Surface Dryness: Patients with severe dry eye syndrome.
- •Systemic Diseases: Patients with systemic diseases that may affect the nervous or immune systems, such as diabetes, rheumatoid arthritis, autoimmune diseases, etc.
- •Recent Use of Systemic Immunosuppressants: Patients who have recently used systemic immunosuppressive agents.
- •Poor Compliance: Patients who are unable to follow up on time or adhere to the treatment plan.
- •Pregnancy or Lactation: Pregnant or nursing women, as their physiological state may affect study outcomes.
- •Allergy History: Patients with a history of allergies to the study medication or related components.
- •Other Reasons: Patients deemed by the investigator to have other reasons making them unsuitable for participation in the trial.
研究组 & 干预措施
Experimental group
The experimental group received intrastromal corneal injections of anti-VEGF (Vascular Endothelial Growth Factor) medication in conjunction with antiviral medication therapy.
干预措施: Intrastromal anti-VEGF injection and topical antiviral eye drops (Drug)
Control group
The control group was treated with conventional antiviral topical ocular drops.
干预措施: Conventional antiviral topical ocular drops. (Drug)
结局指标
主要结局
Change in Neovascularization Area
时间窗: 1、2、4、8、12 week
Corneal Clarity Score
时间窗: 1、2、4、8、12 week
Best Corrected Visual Acuity (BCVA)
时间窗: 1、2、4、8、12 week
Conjunctival Hyperemia Score
时间窗: 1、2、4、8、12 week
Corneal Endothelial Cell Count
时间窗: 1、2、4、8、12 week
次要结局
未报告次要终点