Evaluation of Combined Fine-needle Diathermy and Subconjunctival Bevacizumab Injection in the Treatment of Corneal Neovascularization
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of combined fine-needle diathermy and subconjunctival Bevacizumab injection in patients with corneal neovascularization.
The main questions it aims to answer are:
Does combined fine-needle diathermy and subconjunctival Bevacizumab injection promote regression of corneal neovascularization? Is the treatment safe and well tolerated by patients?
Participants will:
Undergo a baseline evaluation, including assessment of disease duration, ocular history, systemic medical history, and presenting symptoms.
Undergo a detailed ophthalmic evaluation, including best-corrected visual acuity, intraocular pressure measurement, slit-lamp examination, corneal photography, and anterior segment optical coherence tomography (AS-OCT). Provide informed consent after explanation of potential risks and benefits of the procedure.
详细描述
- Background and Rationale Corneal neovascularization (CNV) is a pathological condition characterized by the ingrowth of blood vessels from the limbal vascular plexus into the normally avascular cornea. CNV has various etiologies, including infectious keratitis, inflammatory ocular surface diseases, trauma, chemical injury, contact lens-related complications, limbal stem cell deficiency, and other corneal disorders. The presence of corneal neovascularization can affect corneal transparency, induce lipid deposition and scarring, reduce visual acuity, and increase the risk of corneal graft rejection.
Many treatment modalities have been used to manage CNV, including topical corticosteroids, laser photocoagulation, anti-vascular endothelial growth factor (anti-VEGF) therapy, and fine-needle diathermy (FND). Fine-needle diathermy directly occludes established corneal blood vessels and has demonstrated effectiveness in reducing mature corneal neovascularization. Bevacizumab, a monoclonal antibody against vascular endothelial growth factor (VEGF), inhibits angiogenesis and may reduce the formation and recurrence of corneal neovessels. The combination of FND and subconjunctival bevacizumab injection may provide a synergistic therapeutic effect by targeting both existing vessels and VEGF-mediated angiogenesis.
Although both fine-needle diathermy and bevacizumab have been used individually in the treatment of corneal neovascularization, there is currently limited evidence regarding the long-term efficacy and safety of combining these two treatment modalities. Most published studies have involved small sample sizes, short follow-up periods, or have focused primarily on the outcomes of either fine-needle diathermy or anti-VEGF therapy alone. 2. Objectives Primary objective: to evaluate corneal neovascularization regression at 12 months after combined fine-needle diathermy and subconjunctival Bevacizumab injection.
Secondary Objective: to assess the visual acuity, corneal clarity, recurrence of neovascularization, and treatment-related adverse events. 3. Study design:
This is a prospective, single-arm, interventional clinical trial conducted at the Cornea Department of HoChiMinh City Eye Hospital. This study will enroll a total of 51 eyes.
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 over 18 years.
- •Diagnosis of corneal neovascularization involving at least one quadrant of the cornea, confirmed by slit-lamp examination.
- •Corneal neovascularization is stable with no evidence of progression for at least 4 weeks.
- •Agreement to participate in the study and ability to comply with outpatient follow-up requirements
排除标准
- •Pregnant or breastfeeding women.
- •History of hypersensitivity or allergy to bevacizumab or any component of the study medication.
- •Presence of severe systemic disease that would preclude study participation or surgical intervention, including coagulation disorders or uncontrolled cardiovascular disease.
- •Active ocular infection or acute conjunctivitis at the time of enrollment.
- •Persistent corneal epithelial defect or delayed corneal epithelial healing.
- •History of ocular surgery within 3 months before study enrollment.
- •Corneal neovascularization associated with uncontrolled secondary glaucoma.
- •Inability or unwillingness to comply with study treatment or follow-up visits.
研究者
Le Nhat Minh
Lecturer And Ophthalmologist
HoChiMinh City Eye Hospital