Intravitreal Ranibizumab (Lucentis®) for Neovascular Glaucoma- a Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 28
- 主要终点
- Intraocular pressure
研究概览
简要总结
Neovascular glaucoma is a potentially blinding condition characterized by the growth of newvessels at the anterior part of the eye. This growth is driven by the overexpression of a protein called Vascular Endothelial Growth Factor (VEGF). That happens in diseases such as diabetic retinopathy or venous retinal occlusion, and lead to a fast increase in intraocular pressure (IOP). Traditional treatment include laser photocoagulation of the retina in order to decrease VEGF formation. The investigators postulate that the use of anti-VEGF intravitreal injections may accelerate recovery and decrease the need of surgery in cases of neovascular glaucoma.
详细描述
This is a prospective, randomized controlled study that aims to evaluate the efficacy of ranibizumab (Lucentis®) as an adjunct in the treatment of patients with neovascular glaucoma.
28 patients with neovascular glaucoma (14 in the study group and 14 in the control standard of care group) will be recruited at a single center- University of Sao Paulo Medical School General Hospital. A complete ophthalmologic exam will be carried out, including the obtention of an informed consent for eligible patients willing to participate on the study.
Patients will be randomly assigned to either standard of care- retinal laser photocoagulation and clinical management of intraocular pressure with drops, or standard of care plus intravitreal ranibizumab injections. Two injections will be performed 30 days apart. The patients will be followed for 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IOP greater than 24 mmHg
- •Iris or anterior chamber neovascularization
- •At least 120 degrees of opened anterior chamber angle
排除标准
- •Visual acuity worse than counting fingers in the fellow eye
- •No light perception in the treated eye
- •Any ocular infectious disease
- •Use of systemic steroids
- •Lack of media transparency precluding laser photocoagulation
- •Thromboembolic disease
- •Known hypersensitivity to ranibizumab
- •Female participants at childbearing age not using oral contraceptives
- •Use of intravitreal anti-VEGF over the last 30 days.
研究组 & 干预措施
Ranibizumab
Standard of care therapy plus intravitreal ranibizumab injections
干预措施: Intravitreal ranibizumab (Drug)
Control
Standard of care therapy
干预措施: Intravitreal ranibizumab (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: 6 months
次要结局
- Anterior segment neovascularization(6 months)
- Best corrected visual acuity(6 months)
- Number of drugs needed for IOP control(6 months)
- Need for IOP control surgery(6 months)
研究者
LEANDRO CABRAL ZACHARIAS
Attending - Department of Ophthalmology- University of Sao Paulo
University of Sao Paulo General Hospital