Diabetic RetinopathyNCT06198543
Study on Exosome Changes in Patients With Proliferative Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects enrolled in this study were patients over 18 years of age who signed an informed consent form requiring vitrectomy treatment. Subjects in the experimental group were patients with proliferative diabetic retinopathy, and those in the control group were patients who did not have diabetes but had macular holes or epiretinal membranes. Those with the following conditions could not be enrolled in the study:1) Suffering from cancer, immune diseases, infectious diseases and other systemic diseases;2) Patients with retinal arteriovenous obstruction;3) Intraocular infection;4) Patients with uveitis;5) In patients with high myopia, the equivalent spherical lens was > -9.0D;6) Recent history of cerebral infarction, myocardial infarction and other thrombus;7) Patients with contraindications to surgery.
Who may be able to join
- Age ≥18 years old;
- Patients diagnosed with PDR by FFA and requiring vitrectomy for treatment;
- Patients with no history of diabetes and diagnosed with macular anterior membrane or macular hiatus by color fundus photography and OCT;
- Sign the informed consent form.
Who cannot join
- Suffering from cancer, immune diseases, infectious diseases and other systemic diseases;
- Patients with retinal arteriovenous obstruction;
- Intraocular infection;
- Patients with uveitis;
- In patients with high myopia, the equivalent spherical lens was > -9.0D;
- Recent history of cerebral infarction, myocardial infarction and other thrombus;
- Patients with contraindications to surgery.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
一、Research Purpose
- compared the changes of exosomes in intraocular fluid and blood of patients with proliferative diabetic retinopathy and non-diabetic patients.
- 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
- 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.
- Sample Size A total of 60 patients were included in the study.
- Grouping of Subjects Experimental group: proliferative diabetic retinopathy; Control group: patients with macular epiretinal membranes and macular holes without diabetes.
- Conditions
- Diabetic Retinopathy
- Keywords
- plasma, aqueous humor, vitreous humor, exosomes, proteomics
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | proliferative diabetic retinopathy | |
| control group | patients with macular epiretinal membranes and macular holes without diabetes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
differential proteins of exosomes
Exosomes from plasma, atrial fluid and vitreous fluid were isolated and extracted, and proteomic analysis of proteins in exosomes was performed to analyse the number of differentially expressed protein species in the test and control groups, and bioinformatics analysis of up-regulated or down-regulated expressed proteins was performed.
Measured: January 2024 - January 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198543
- Sponsor's protocol ID
- wuhang
- Status last verified
- Nov 2023
- First submitted
- 11 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Exosome Changes in Patients With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06198543
- Acronym / sponsor ID
- wuhang
- Conditions
- Diabetic Retinopathy
- Keywords
- plasma, aqueous humor, vitreous humor, exosomes, proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
一、Research Purpose
- compared the changes of exosomes in intraocular fluid and blood of patients with proliferative diabetic retinopathy and non-diabetic patients.
- 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
- 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.
- Sample Size A total of 60 patients were included in the study.
- Grouping of Subjects Experimental group: proliferative diabetic retinopathy; Control group: patients with macular epiretinal membranes and macular holes without diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | –proliferative diabetic retinopathy |
| control group | – | –patients with macular epiretinal membranes and macular holes without diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects enrolled in this study were patients over 18 years of age who signed an informed consent form requiring vitrectomy treatment. Subjects in the experimental group were patients with proliferative diabetic retinopathy, and those in the control group were patients who did not have diabetes but had macular holes or epiretinal membranes. Those with the following conditions could not be enrolled in the study:1) Suffering from cancer, immune diseases, infectious diseases and other systemic diseases;2) Patients with retinal arteriovenous obstruction;3) Intraocular infection;4) Patients with uveitis;5) In patients with high myopia, the equivalent spherical lens was > -9.0D;6) Recent history of cerebral infarction, myocardial infarction and other thrombus;7) Patients with contraindications to surgery.
Key inclusion criteria (4 listed)
- Age ≥18 years old;
- Patients diagnosed with PDR by FFA and requiring vitrectomy for treatment;
- Patients with no history of diabetes and diagnosed with macular anterior membrane or macular hiatus by color fundus photography and OCT;
- Sign the informed consent form.
Key exclusion criteria (7 listed)
- Suffering from cancer, immune diseases, infectious diseases and other systemic diseases;
- Patients with retinal arteriovenous obstruction;
- Intraocular infection;
- Patients with uveitis;
- In patients with high myopia, the equivalent spherical lens was > -9.0D;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differential proteins of exosomes
Time frame: January 2024 - January 2025
Exosomes from plasma, atrial fluid and vitreous fluid were isolated and extracted, and proteomic analysis of proteins in exosomes was performed to analyse the number of differentially expressed protein species in the test and control groups, and bioinformatics analysis of up-regulated or down-regulated expressed proteins was performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hang Wu, Master (+8613911993866, wuhang2317@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differential proteins of exosomes (time frame: January 2024 - January 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.