Surrogate electroretinographic markers for assessing therapeutic efficacy in the retina

被引:8
作者
Birch, DG [1 ]
机构
[1] Retina Fdn SW, Dallas, TX 75231 USA
关键词
AMD; a-wave; clinical trials; electroretinography; focal ERG; maculas degeneration; multifocal ERG; pattern ERG; retina; retinitis piginentosa; treatment; visual acuicy;
D O I
10.1586/14737159.4.5.693
中图分类号
R36 [病理学];
学科分类号
100104 ;
摘要
Visual acuity remains the primary surrogate marker for clinical trials In ophthalmology (and the primary outcome for most US Food and Drug Administration applications) due to its long history, ease of measurement and clear relationship to clinically meaningful characteristics of daily life. However, treatment trials are being planned for diseases that are currently untreatable where visual acuity may not be the most appropriate outcome measure. Specialized electroretinographic tests can be powerful surrogate markers In such trials. The selection of outcome measures and surrogate markers depends in part on whether the goal is to preserve remaining vision in a progressive retinal degeneration or to improve vision In an eye that has already undergone extensive degeneration. Among the electroretinographic tests available are those involving the whole retina (full-field electroretinographic), the posterior pole (pattern electroretinographic) or focal areas within the macula (multifocal electroretinographic). The advantages and disadvantages of each will be discussed along with selected applications of each test to a specific category of disease.
引用
收藏
页码:693 / 703
页数:11
相关论文
共 42 条
[41]  
SANDBERG MA, 1977, ARCH OPHTHALMOL-CHIC, V95, P1881
[42]   THE FIELD TOPOGRAPHY OF ERG COMPONENTS IN MAN .1. THE PHOTOPIC LUMINANCE RESPONSE [J].
SUTTER, EE ;
TRAN, D .
VISION RESEARCH, 1992, 32 (03) :433-446