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临床试验/NCT00347698
NCT00347698撤回2 期

Intravitreal Bevacizumab vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-year Prospective, Contralateral Eye Study

Asociación para Evitar la Ceguera en México2 个研究点 分布在 1 个国家开始时间: 2006年3月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
撤回
发起方
试验地点
2
主要终点
Median deviation in visual fields at one year

研究概览

简要总结

The purpose of the study is to evaluate the safety and efficacy of 2.5 mg of intravitreal bevacizumab in one eye, versus panretinal photocoagulation in the contralateral eye, for the treatment of patients with untreated symmetric proliferative diabetic retinopathy.

详细描述

The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. However, it is a treatment that results in significant discomfort to the patient, causes reduction of visual acuity and visual field impairment. Intravitreal bevacizumab is a novel treatment that reduces intraocular VEGF concentration and therefore inhibits neovascular proliferation, without causing significant disconfort to the patient, nor affecting visual acuity or visual fields (although with other risks associated with intravitreal injection). Making a comparison between both treatments in different patients is difficult because there are other variables that influence the progression of the disease (such as glycemic control or renal insufficiency). Therefore this study is designed using both treatments in the same patient: intravitreal bevacizumab in one eye, compared to panretinal photocoagulation in the contralateral eye, and evaluating visual acuity, visual fields, fluorescein angiography, optic coherence tomography of the macula, and patient discomfort, in a one-year follow-up.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • symmetric proliferative diabetic retinopathy without high risk characteristics
  • age 18 years or older
  • patient consent

排除标准

  • heart attack or cerebrovascular attack
  • retinal detachment
  • vitreous haemorrhage
  • previous treatment for diabetic retinopathy
  • media opacities that preclude visualization of the fundus
  • pregnancy
  • inability to understands the implications of the protocol

结局指标

主要结局

Median deviation in visual fields at one year

Score on a patient satisfaction scale at six months and one year

Macular thickness measured by OCT at six months and one year

Best corrected visual acuity at six months and one year

次要结局

  • Complications associated to each treatment

研究者

发起方
Asociación para Evitar la Ceguera en México
申办方类型
Other

研究点 (2)

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