Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198543
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-11
Brief Title:
Study on Exosome Changes in Patients With Proliferative Diabetic Retinopathy
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Study on Exosome Changes in Patients With Proliferative Diabetic Retinopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Diabetic retinopathy is a common complication of diabetes and one of the leading causes of low vision and blindness in adults In recent years the prevalence of diabetes and the incidence of diabetic retinopathy have increased significantly in our country Epidemiological studies show that the prevalence rate of diabetes in China is 128 and the prevalence rate of DR in adult diabetic patients is 247-375 that is there are about 3200-48 million DR patients in China and the patients have a trend of younger people DR has become a serious public health problem threatening peoples lives and health
At present it is known that the pathogenesis of DR is related to hypoxia oxidative stress inflammation abnormal expression of cytokines and gene methylation but the specific pathogenesis has not been fully clarified Due to the hidden early symptoms of DR the lack of basic screening conditions in primary medical and health institutions and the lack of awareness of DR by patients themselves many DR patients have already appeared serious retinopathy when they seek medical treatment resulting in irreversible visual function impairment In addition the current clinical treatment methods for DR mainly include retinal photocoagulation therapy intraocular anti-VEGF drug injection and vitrectomy surgery etc These methods are aimed at relatively severe diabetic retinopathy and there is no effective treatment method for early diabetic retinopathy that can prevent or slow down the occurrence and development of DR Therefore to further explore the pathogenesis of DR and develop new therapeutic methods has become an urgent problem
Exosomes are extracellular vesicles secreted by living cells with a diameter of 40-150nm With a bilayer lipid membrane structure exosomes contain a variety of biomolecules such as lipids proteins nucleic acids cytokines and autoantigens and are important mediators for the transmission of biological information between cells Almost all cells can secrete exosomes and exosomes from different cells have different functions Exosomes transfer their contents to nearby or distant cells and participate in cell growth angiogenesis immune regulation and other processes Previous studies have shown that exosomes secreted by various cells in the retina are present in the vitreous and aqueous humor of patients and play an important role in the pathogenesis of DR At the same time exosomes in the systemic circulation of diabetic patients can also reach the retina through the blood circulation participate in the initiation process of DR And play an important role At the same time due to the double-layer lipid membrane structure exosomes can also target the coated components to specific cells and tissues through biological barriers such as blood-brain and blood-eye which is expected to become a highly efficient drug delivery route Therefore the role of exosomes in DR Treatment has also attracted much attention
At present it is known that the pathogenesis of DR is related to hypoxia oxidative stress inflammation abnormal expression of cytokines and gene methylation but the specific pathogenesis has not been fully clarified Due to the hidden early symptoms of DR the lack of basic screening conditions in primary medical and health institutions and the lack of awareness of DR by patients themselves many DR patients have already appeared serious retinopathy when they seek medical treatment resulting in irreversible visual function impairment In addition the current clinical treatment methods for DR mainly include retinal photocoagulation therapy intraocular anti-VEGF drug injection and vitrectomy surgery etc These methods are aimed at relatively severe diabetic retinopathy and there is no effective treatment method for early diabetic retinopathy that can prevent or slow down the occurrence and development of DR Therefore to further explore the pathogenesis of DR and develop new therapeutic methods has become an urgent problem
Exosomes are extracellular vesicles secreted by living cells with a diameter of 40-150nm With a bilayer lipid membrane structure exosomes contain a variety of biomolecules such as lipids proteins nucleic acids cytokines and autoantigens and are important mediators for the transmission of biological information between cells Almost all cells can secrete exosomes and exosomes from different cells have different functions Exosomes transfer their contents to nearby or distant cells and participate in cell growth angiogenesis immune regulation and other processes Previous studies have shown that exosomes secreted by various cells in the retina are present in the vitreous and aqueous humor of patients and play an important role in the pathogenesis of DR At the same time exosomes in the systemic circulation of diabetic patients can also reach the retina through the blood circulation participate in the initiation process of DR And play an important role At the same time due to the double-layer lipid membrane structure exosomes can also target the coated components to specific cells and tissues through biological barriers such as blood-brain and blood-eye which is expected to become a highly efficient drug delivery route Therefore the role of exosomes in DR Treatment has also attracted much attention
Detailed Description:
一Research Purpose
1 compared the changes of exosomes in intraocular fluid and blood of patients with proliferative diabetic retinopathy and non-diabetic patients
2 analysed differentially expressed proteins in the exosomes of the two groups of patients using proteomic techniques laying the foundation for screening possible biomarkers and potential therapeutic targets for the early diagnosis of diabetic retinopathy
二Design
1 Subject Population Patients with proliferative diabetic retinopathy and non-diabetic macular epiretinal membranemacular hole requiring vitrectomy were admitted to the Ophthalmology Department of Xuanwu Hospital Capital Medical University
2 Sample Size A total of 60 patients were included in the study
3 Grouping of Subjects Experimental group proliferative diabetic retinopathy Control group patients with macular epiretinal membranes and macular holes without diabetes
1 compared the changes of exosomes in intraocular fluid and blood of patients with proliferative diabetic retinopathy and non-diabetic patients
2 analysed differentially expressed proteins in the exosomes of the two groups of patients using proteomic techniques laying the foundation for screening possible biomarkers and potential therapeutic targets for the early diagnosis of diabetic retinopathy
二Design
1 Subject Population Patients with proliferative diabetic retinopathy and non-diabetic macular epiretinal membranemacular hole requiring vitrectomy were admitted to the Ophthalmology Department of Xuanwu Hospital Capital Medical University
2 Sample Size A total of 60 patients were included in the study
3 Grouping of Subjects Experimental group proliferative diabetic retinopathy Control group patients with macular epiretinal membranes and macular holes without diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None