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临床试验/NCT00411333
NCT00411333已完成早期 1 期

Vascular Remodeling and the Effects of Angiogenic Inhibition in Diabetic Retinopathy

National Eye Institute (NEI)2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2006年7月最近更新:
适应症
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Change in retinal vascular density from baseline on fluorescein angiography

研究概览

简要总结

The retinal vasculature changes dramatically in patients with diabetic retinopathy especially between non-proliferative and proliferative disease. The retinal vasculature can be imaged and quantified using special dyes. This study will test whether the pattern of the retinal vasculature changes in patients with different levels of diabetic retinopathy can be quantified using computerized image analysis. In addition, the study will evaluate whether new drugs to treat diabetic retinopathy will be able to reverse these vascular changes.

详细描述

In this study, we are studying whether vascular density decreases during diabetic retinopathy prior to the pathological neovascularization seen in proliferative disease that results in blindness in more than 50 percent of patients, and whether the adverse, early vascular remodeling and neovascularization can be reversed by anti-angiogenic therapeutics. We have shown that vascular density decreases during early stages of diabetic retinopathy, prior to the pathological neovascularization that defines proliferative retinopathy, and that this change may be reversible with new anti-angiogenic therapeutics. To test this hypothesis we will determine (1) how blood vessels remodel and whether vascular density truly decreases during diabetic retinopathy and (2) how the anti-angiogenic steroid triamcinolone acetonide affects vascular density and pattern during human diabetic retinopathy and in our experimental model, the avian CAM model.

Twenty patients (n = 20) for each of the 4 NPDR stages will be enrolled. In addition, a control group of 20 normal subjects will be recruited from the same clinical practice that do not have diabetes and no evidence of any vascular disease, for a total of 100 patients in the clinical trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Presence of mild, moderate, severe, or very severe non-proliferative diabetic retinopathy (defined as ETDRS level >10) in at least one eye (based on ETDRS criteria)

排除标准

  • Any condition that might impair the patient's ability to give informed consent
  • Any condition or media opacity that might impair the patient's ability to perform vision tests, color fundus photographs or fluorescein angiography
  • Severe allergy or other contraindication to sodium fluorescein dye
  • Participating in any other ophthalmic clinical trial

结局指标

主要结局

Change in retinal vascular density from baseline on fluorescein angiography

次要结局

  • Safety

研究者

申办方类型
Nih

研究点 (2)

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