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青光眼临床研究:治疗策略与药物研发趋势

Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development.

作者信息

Storgaard Line, Tran Thuy Linh, Freiberg Josefine Clement, Hauser Alexander S, Kolko Miriam

机构信息

Department of Drug Design and Pharmacology, University of Copenhagen, Copenhagen, Denmark.

Department of Ophthalmology, Copenhagen University Hospital, Rigshospitalet-Glostrup, Copenhagen, Denmark.

出版信息

Front Med (Lausanne). 2021 Sep 13;8:733080. doi: 10.3389/fmed.2021.733080. eCollection 2021.

Abstract

To investigate the trends and progresses in glaucoma research by searching two major clinical trial registries; clinicaltrials.gov, and Australianclinicaltrials.gov.au. All clinical trials with glaucoma covered by Clinicaltrials.gov, and Australianclinicaltrials.gov.au starting the study before 1 January 2021 were included. Trials evaluating glaucoma treatment were separated from non-treatment trials and divided into three major categories: "laser treatment," "surgical treatment," and "medical treatment." In the category of "medical treatment," new compounds and their individual targets were identified and subcategorized according to treatment strategy; intraocular pressure (IOP)-lowering, neuroprotective or vascular. The phase transition success rates were calculated. One-thousand five hundred and thirty-seven trials were identified. Sixty-three percent ( = 971) evaluated glaucoma treatment, of which medical treatment accounted for the largest proportion (53%). The majority of medical trials evaluated IOP-lowering compounds, while trials with neuroprotective or vascular compounds accounted for only 5 and 3%, respectively. Eighty-eight new compounds were identified. Phase I, II, and III transition success rates were 63, 26, and 47%, respectively. The number of clinical trials in glaucoma research has increased significantly over the last 30 years. Among the most recently evaluated compounds, all three main treatment strategies were represented, but clinical trials in neuroprotection and vascular modalities are still sparse. In addition to traditional medicines, dietary supplements and growth factors are assessed for a potential anti-glaucomatous effect. Phase II and III success rates were below previously reported success rates for all diseases and ophthalmology in general. A stricter phenotyping of patients can improve the success rates in glaucoma and ophthalmological research and gain a better understanding of responders and non-responders.

摘要

通过检索两个主要临床试验注册库Clinicaltrials.gov和Australianclinicaltrials.gov.au,调查青光眼研究的趋势和进展。纳入Clinicaltrials.gov和Australianclinicaltrials.gov.au中在2021年1月1日前开始研究的所有青光眼临床试验。评估青光眼治疗的试验与非治疗试验分开,并分为三大类:“激光治疗”、“手术治疗”和“药物治疗”。在“药物治疗”类别中,识别新化合物及其各自靶点,并根据治疗策略进行细分:降低眼压、神经保护或血管相关。计算各阶段转换成功率。共识别出1537项试验。63%(=971项)评估青光眼治疗,其中药物治疗占比最大(53%)。大多数药物试验评估降低眼压的化合物,而神经保护或血管相关化合物的试验分别仅占5%和3%。识别出88种新化合物。I期、II期和III期转换成功率分别为63%、26%和47%。在过去30年中,青光眼研究的临床试验数量显著增加。在最近评估的化合物中,代表了所有三种主要治疗策略,但神经保护和血管治疗方式的临床试验仍然较少。除传统药物外,还评估了膳食补充剂和生长因子的潜在抗青光眼作用。II期和III期成功率低于先前报道的所有疾病和眼科总体成功率。对患者进行更严格的表型分析可以提高青光眼和眼科研究的成功率,并更好地了解反应者和无反应者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b38/8473801/9c9cff00dfca/fmed-08-733080-g0001.jpg

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