中国视网膜下基因治疗药物注射术操作专家共识

标题: 中国视网膜下基因治疗药物注射术操作专家共识
title: Expert consensus on surgical technique for subretinal injection of gene therapy in China
版本: 原创版
version: Original
分类: 专家共识
classification: Experts consensus
领域: 治疗
field: Treatment
国家和地区: 中国
Country and region: China
指南使用者:
Guide users:
证据分级方法: 不适用
Evidence grading method: Not Applicable
制定单位: 中华医学会眼科学分会眼底病学组;中国医师协会眼科医师分会眼底病专业委员会
Formulating unit: Fundus Disease Group of Chinese Medical Association Ophthalmology Branch; Fundus Disease Committee of Chinese Medical Doctor Association Ophthalmology Branch
注册时间: 2022-06-18
Registration time:
注册编号: IPGRP-2022CN349
Registration number:
指南制订的目的: 随着具有里程碑意义的Luxturna应用于临床,基因治疗在眼科领域蓬勃发展。视网膜下注射技术已经成为治疗遗传性视网膜疾病(IRDs)等眼底病变的重要给药途径之一。基因治疗的效果、病毒载体的分布、免疫反应的程度均取决于能否安全有效地将药物递送至视网膜下空间。视网膜下基因治疗药物注射术的特点是在玻璃体视网膜手术基础上叠加独特的给药操作,使基因治疗精准作用于目标区域。目前我国IRDs基因治疗处于起步阶段,有必要依据现有国内外临床实践,制定一个详细完整的视网膜下注射基因治疗药物操作的专家共识,助力于开展IRDs等眼底病变相关的基因治疗临床研究。随着基因治疗技术发展,相关内容将不断完善更新。
Purpose of the guideline: With the introduction of landmark genetic product, Luxturna, into clinical application, gene therapy is widely development in ophthalmology. Subretinal injection technique has become one of the important methods to treat inherited retinal diseases (IRDs) and other fundus diseases. The efficacy of gene therapy, distribution of viral vector and immune response mainly depend on the safe and efficient delivery of drugs into the subretinal space. The subretinal injection of gene therapy is characterized by the addition of unique drug delivery opeartion on the basis of vitreoretinal surgery, so that the therapeutic gene can accurately reach the target. Currently, IRDs gene therapy has just started in China. Therefore, it is necessary to develop a detailed and complete surgical procedure for subretinal injection of gene therapy according to the current domestic and abroad clinical practice. The protocol may facilitate the development of gene therapy related to IRDs and fundus diseases. With the development of genetic technology, the relevant content will be constantly updated.