【ChiCTR2600131951】The effect of Sodium-Glucose Cotransporter-2 Inhibitors and Dipeptidyl Peptidase-4 Inhibitors on Diabetic Retinal Disease

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基本信息

登记号

ChiCTR2600131951

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-09-08

临床申请受理号

靶点

适应症

Diabetes retinopathy

试验通俗题目

The effect of Sodium-Glucose Cotransporter-2 Inhibitors and Dipeptidyl Peptidase-4 Inhibitors on Diabetic Retinal Disease

试验专业题目

The effect of Sodium-Glucose Cotransporter-2 Inhibitors and Dipeptidyl Peptidase-4 Inhibitors on Diabetic Retinal Disease

申办单位信息

申请人联系人

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

Aim 1: To evaluate the effect of SGLT-2i, DPP-4i, or their combination on the development and progression of DR, PDR, and DME. Aim 2: To evaluate the effect of SGLT-2i and DPP-4i on the rate of thinning of the macular ganglion cell-inner plexiform layer (GCIPL) and macular retinal nerve fiber layer (RNFL). Aim 3: To assess and compare the change in a serial quantitative optical coherence tomography-angiography (OCT-A) metric among four groups, including only SGLT-2i, DPP-4i, both medications, and control. Aim 4: To estimate and compare the rate of thinning in macular GCIPL and macular RNFL before and after the initiation of SGLT-2i and DPP-4i usage.

试验分类

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试验类型

横断面

试验分期

回顾性研究

随机化

None

盲法

试验项目经费来源

Department of Ophthalmology and Visual Sciences (DOVS), Chinese University of Hong Kong

试验范围

目标入组人数

500

实际入组人数

第一例入组时间

2026-10-01

试验终止时间

2029-05-31

是否属于一致性

入选标准

1. Participants who had been followed for at least three years after baseline visit from Hong Kong Eye Hospital (HKEH) (KC/KE-15-0137/ER-3) between 29 July 2015 and 26 July 2021 and Prince of Wales Hospital (PWH) (CRE2016.511) between 7 February 2017 and 29 June 2021; 2. Participants with complete medication records from the time of enrollment in the cohort study; 3. For participants receiving SGLT-2i or DPP-4i, only those who initiated these drugs after the baseline examination will be included (i.e., new-user design); 4. Participants receiving neither SGLT-2i nor DPP-4i will be included in the control group. 1. Participants who had been followed for at least three years after baseline visit from Hong Kong Eye Hospital (HKEH) (KC/KE-15-0137/ER-3) between 29 July 2015 and 26 July 2021 and Prince of Wales Hospital (PWH) (CRE2016.511) between 7 February 2017 and 29 June 2021;2. Participants with complete medication records from the time of enrollment in the cohort study;3. For participants receiving SGLT-2i or DPP-4i, only those who initiated these drugs after the baseline examination will be included (i.e., new-user design);4. Participants receiving neither SGLT-2i nor DPP-4i will be included in the control group.；

排除标准

Participants, eyes, or images that met the following exclusion criteria: 1. Participants received GLP-1RA during the study period; 2. Participants without post-medication images after adopting the new-user design; 3. Eyes with ungradable FP or OCT scans, for example, due to media opacities; 4. Eyes with established PDR or DME prior to the commencement of the medications.；

研究者信息

研究负责人姓名

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试验机构

Department of Ophthalmology and Visual Sciences (DOVS), Chinese University of Hong Kong

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