跳至主要内容
临床试验/NCT02979665
NCT02979665已完成不适用

A Clinico-Pathological Study of the Structural and Functional Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema

Lawson Health Research Institute0 个研究点目标入组 51 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
51
主要终点
Effects of anti-VEGF drugs on intraocular pressure (mmHg)

研究概览

简要总结

anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on the overall retinal perfusion from these treatments remain to be answered. The purpose of the study was to evaluate changes in the retina following anti-VEGF treatment over time, using structural and functional diagnostic tests.

详细描述

Diabetic retinopathy (DR) causes changes in the capillaries that nourish the retina. Two treatments clinically used for DR are laser photocoagulation to reduce the angiogenic drive by knocking off metabolically active retina and anti-VEGF drugs for diabetic macular edema (DME). DME affects approximately 2.5% of the nearly 2.4 million Canadians with diabetes, or approximately 60,000 Canadians, making it a major cause of adult-onset vision loss. DME occurs when blood vessels in the retina of diabetic patients become leaky resulting in unwanted fluid accumulation in the center of vision known as the macula. If not treated, this can lead to blindness. Originally used in the treatment of age-related macular degeneration (AMD), anti-VEGF drugs are increasingly used to control leakage and abnormal growth of retinal blood vessels. Numerous questions have emerged following the usage of anti-VEGF medications in the eye such as their long-term effects of these drugs on intraocular pressure and on the overall retinal perfusion. By recruiting DR patients requiring anti-VEGF treatment for DME, this study will answer whether long-term usage of anti-VEGF will result in structural and functional changes to the retina.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • DME patients
  • Require anti-VEGF injections in at least one eye

排除标准

  • Advanced lens opacity or cataract that could affect diagnostic testing
  • Prior retinal treatment (PRP, focal laser or surgery within 6 months of participation)

研究组 & 干预措施

Ranibizumab Ophthalmic

DME consults requiring anti-VEGF treatment

干预措施: Ranibizumab Ophthalmic (Drug)

结局指标

主要结局

Effects of anti-VEGF drugs on intraocular pressure (mmHg)

时间窗: 2 year

次要结局

  • Effects of anti-VEGF drugs on macular thickness (um)(2 year)

研究者

申办方类型
Other
责任方
Sponsor

相似试验