Clinical Trial 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 12.8%, and the
prevalence rate of DR in adult diabetic patients is 24.7%-37.5%, 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 people's 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.
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 membrane/macular 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.
