Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Failure rates of the surgery as defined by intraocular pressure reductions
研究概览
简要总结
Trabeculectomy with mitomycin C remains the standard surgery for glaucoma. This surgery involves creating a door in the eye wall in order to improve fluid outflow and decrease intraocular pressure. However, success rates range from 70% to 90% depending on the criteria used and tend to decrease with time. The failure of the surgery is associated with inflammation, new blood vessel formation and scarring which can cause closure of the door. Molecules which inhibit new blood vessel formation such as inhibitors of vascular endothelial growth factor have been used successfully to decrease scarring in animal eyes where little doors were created and significantly improve survival. Furthermore, they have shown promise when used during trabeculectomy. Ranibizumab, a vascular endothelial growth factor, has also been used safely in intraocular surgery to treat other diseases which involve new blood vessel formation such as macular degeneration and diabetes.
The investigators hypothesize that ranibizumab may decrease the failure rate of trabeculectomy with mitomycin C by decreasing scarring.
The aim of the study is to evaluate the difference in failure rates and bleb morphology at one year post-operatively in eyes having undergone sub-conjunctival injections of ranibizumab in addition to primary trabeculectomy with mitomycin C compared to eyes having undergone trabeculectomy with mitomycin C alone.
详细描述
Prospective, randomized, unblinded clinical trial. Two groups of patients with glaucoma undergoing primary trabeculectomy or phaco-trabeculectomy with MMC between March 2009 and September 2012. The ranibizumab group (RAN) received 2 subconjunctival injections of 0.5 mg of ranibizumab (intraoperatively and on day 14) and he control group did not receive ranibizumab.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to have uncontrolled glaucoma
- •to have accepted to undergo a primary trabeculectomy with mitomycin C
- •to have one of the following types of glaucoma:
- •Normal tension Glaucoma
- •Chronic Open-Angle Glaucoma
- •Chronic Angle-Closure Glaucoma
- •Mixed mechanism glaucoma
- •Steroid-induced Glaucoma
- •Neovascular Glaucoma
排除标准
- •to be less than 18 years old
- •to be unable to observe the study protocol
- •to present some risk factors for thromboembolic events and cerebrovascular accidents : hypertension, dyslipidemia, coronary artery diseases
- •a history of thromboembolic events and cerebrovascular accidents
- •congenital glaucoma
- •uveitic glaucoma
- •to be pregnant
- •to be breastfeeding
- •surgical complications prior to injection of the study drug such as vitreous in the anterior chamber or the presence of suprachoroidal hemorrhages
- •to have undergone a previous conjunctival surgery
- •to be hypersensitive to the drug, to one of the components of the drug or to one of the components of the packaging
- •to present an active or suspected intraocular or periocular inflammation
- •to have a kidney failure
- •to have a liver failure
研究组 & 干预措施
ranibizumab
Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively
干预措施: ranibizumab (Drug)
standard care
Trabeculectomy with mitomycin C and standard post-operative care
干预措施: standard care (Procedure)
结局指标
主要结局
Failure rates of the surgery as defined by intraocular pressure reductions
时间窗: one year
Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications. Qualified success: similar definition with the use of glaucoma medications.
次要结局
- Bleb morphology using Moorfields bleb grading system(one year)
研究者
Gisele Li
Assistant Professor
Maisonneuve-Rosemont Hospital
