Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Neovascularisation reduction at 3 months
研究概览
简要总结
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.
This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo
详细描述
This study will involve 42 outpatients of the CHU of Limoges, Bordeaux, and Toulouse, addressed for corneal pathologies including corneal newvessels. The patients will be randomly assigned to two groups, one receiving three subconjunctival injections of bevacizumab, the other three subconjunctival injections of placebo (Balanced salt solution). The progression of newvessels will be assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels. Randomization, and preparation of both study drug and placebo syringes will be performed by the central pharmacy of the CHU de Limoges. Patients will be followed-up as outpatients, with visits scheduled 15 days before treatment, at baseline, and then at 1 month, 2 months, 3 months, and 6 months.
- Primary outcome: To demonstrate Bevacizumab subconjunctival injections effectiveness on corneal neovascularisation reduction definite by a superior percentage of patient with a reduction higher than 30 % of the corneal surface occupied by newvessels , at 3 months, in the group Bevacizumab compared with the group placebo
- Secondary outcomes:
- The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied by neovascularization at 6 months
- The effectiveness of bevacizumab on reducing the use of corneal graft.
- The local and general toxicity of bevacizumab administered by subconjunctival way.
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
- Double (Participant, 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
- •inclusion criteria:
- •Patients with corneal neovascularization whatever the origin
- •Patient did not receive treatment with topical corticosteroids during the month preceding inclusion.
- •Patient who has been properly informed and signed consent
- •Patient aged over 18
- •Patient affiliated with a health insurance plan or benefit of such a regime
排除标准
- •Patients who received local or general treatment of concomitant prostaglandin derivatives
- •Patients with current infection of the cornea or other tissue / organ
- •Women of childbearing age without contraception
- •Pregnancy and Lactation
- •Patient participating in another study
- •Patient with contact lenses
- •Patients with uncontrolled hypertension
- •Patient with a history of stroke, myocardial infarction, angina pectoris, thrombophlebitis, Raynaud's phenomenon.
- •Patients hypersensitive to the active substance or any excipients
- •Patients hypersensitive to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies.
- •Patients with active bacterial eye infections, fungal, parasitic or viral infection (with the exception of herpes)
研究组 & 干预措施
bevacizumab
Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.
干预措施: bevacizumab (Drug)
Placebo
Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.
干预措施: NaCl (Drug)
结局指标
主要结局
Neovascularisation reduction at 3 months
时间窗: at 3 months
Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target.
次要结局
- Local and general toxicity of bevacizumab(at 1 months, 2 month, 3 month, 6 month)
- Efficacy at 6 months(at 6 month)