Lund-Andersen Henrik
University Hospital Copenhagen, Copenhagen, Denmark.
Surv Ophthalmol. 2002 Dec;47 Suppl 2:S270-7. doi: 10.1016/s0039-6257(02)00386-7.
Trials of new compounds (e.g., protein kinase C inhibitors) for the treatment of diabetic retinopathy and diabetic macular edema historically have used tools such as seven-field stereoscopic fundus photography to grade retinopathy, and endpoints such as the need for retinal photocoagulation to evaluate efficacy. Improvements in diabetes care have led to slower spontaneous progression of retinopathy than anticipated, however. A consequence of this trend is that clinical trials for diabetic retinopathy and diabetic macular edema are expected to last for many years and require large numbers of patients before evidence-based conclusions can be made. Therefore, interest in new assessment tools is growing. This review briefly describes the basic pathophysiologic factors involved in the pathogenesis of diabetic macular edema to provide a basis for the introduction of new quantitative and objective endpoints. Special consideration is given to measuring fluorescein permeability of the blood-retinal barrier. The quantitative measurement of retinal thickness using optical coherence tomography is a promising noninvasive method. Microaneurysm counts, assessment of length and diameter of retinal vessels, and computerized quantification of all pathologic elements may also be useful as diagnostic tools and/or efficacy endpoints.
以往，用于治疗糖尿病性视网膜病变和糖尿病性黄斑水肿的新化合物（如蛋白激酶C抑制剂）试验，使用七视野立体眼底摄影等工具对视网膜病变进行分级，并以是否需要视网膜光凝等终点来评估疗效。然而，糖尿病护理的改善使得视网膜病变的自然进展比预期的要慢。这种趋势的一个结果是，糖尿病性视网膜病变和糖尿病性黄斑水肿的临床试验预计将持续多年，并且在得出基于证据的结论之前需要大量患者。因此，人们对新的评估工具的兴趣与日俱增。本综述简要描述了糖尿病性黄斑水肿发病机制中涉及的基本病理生理因素，为引入新的定量和客观终点提供依据。特别关注测量血视网膜屏障的荧光素通透性。使用光学相干断层扫描对视网膜厚度进行定量测量是一种很有前景的非侵入性方法。微动脉瘤计数、视网膜血管长度和直径的评估以及所有病理成分的计算机量化，也可能作为诊断工具和/或疗效终点有用。
