Randomized Controlled Trial of Lucentis in the Management of New Onset Neovascular Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6.
研究概览
简要总结
Neovascular glaucoma is a potentially debilitating disease of the eye. Vascular eye disease such as diabetes and vein occlusions can cause the retina to release factors that promote the growth of abnormal blood vessels. These abnormal vessels can grow in the drainage mechanism of the eye causing pressure in the eye to markedly increase. This can potentially cause irreversible damage to the optic nerve from glaucoma leading to permanent blindness and painful eyes. Conventional treatments including laser and freezing therapy take weeks to cause regression in abnormal blood vessel growth. This delay often results in permanent vision loss and pain. New medications targeted at more immediately reducing blood vessel growth may aid in the treatment of this disease.
详细描述
Hypothesis:
Intravitreal injection of Lucentis prior to conventional treatment for neovascular glaucoma improves overall outcome compared to conventional treatment alone.
Specific Aims:
To determine if pre-treatment with a single intravitreal injection of Lucentis prior to conventional treatment prevents severe vision loss and improves intraocular pressure control compared to conventional treatment alone.
Neovascular glaucoma is a potentially devastating consequence of fibrovascular proliferation of the anterior chamber angle with subsequent obstruction of the trabecular meshwork. The production of peripheral anterior synechiae along the trabecular meshwork leads to progressive angle closure. The subsequent elevation in intraocular pressure is difficult to manage, often leading to rapid progression of glaucoma and significant loss of vision. Enucleation for blind, painful eyes secondary to neovascular glaucoma is not an uncommon sequelae.
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
- 21 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 > 21 years
- •Diagnosis of neovascular glaucoma (angle neovascularization with or without iris neovascularization and IOP > 21 mm Hg and > 5 mm Hg IOP compared to the fellow eye).
- •Neovascular glaucoma secondary to retinal ischemia (central retinal vein occlusion, proliferative diabetic retinopathy, ocular ischemic syndrome, etc.)
排除标准
- •Pregnancy (positive pregnancy test) or lactation or pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Prior enrollment in the study
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •> 270 degrees of closed trabecular meshwork (closure secondary to peripheral anterior synechiae)
- •History of active inflammatory, infectious, or idiopathic keratitis precluding view of the anterior segment structures.
- •Previous intravitreal injections of ranibizumab or bevacizumab in either eye.
研究组 & 干预措施
1
Lucentis (ranibizumab) with conventional treatment
干预措施: Ranibizumab (Lucentis) (Drug)
结局指标
主要结局
Mean change in best corrected visual acuity (BCVA) as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from baseline to Month 6.
时间窗: Baseline to Month 6.
次要结局
- Percent change in iris neovascularization (measured both in clock hours by slit lamp exam and with iris angiography).(Initial visit through Month 6)
- Mean change in optic nerve cupping.(Initial Visit through Month 6)
- Percent of patients requiring surgical glaucoma procedure to control intraocular pressure (trabeculectomy, seton, or ciliary body destruction).(Study duration)
- Percent of patients requiring pars plana vitrectomy with endolaser.(Study duration)
- Rates of rhegmatogenous retinal detachment.(Study duration)
- Percent change in angle neovascularization (measured in clock hours by gonioscopy).(Initial visit through Month 6)
- Percent change in permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy).(Initial visit through Month 6)
- Number of intraocular pressure lowering medications needed to control intraocular pressure.(Initial Visit through Month 6)
- Rates of endophthalmitis.(Study duration)
- Mean change in intraocular pressure measured by applanation tonometry.(Initial visit through Month 6)
- Rates of severe vision loss (visual acuity <20/200, loss of 6 lines or more on ETDRS chart).(Initial Visit through Month 6)
- Final clock hours of permanent angle closure (clock hours of peripheral anterior synechiae by gonioscopy)(Month 6 visit)
研究者
Michael Blair
Faculty Ophthalmology and Visual Services
University of Illinois at Chicago