Diabetic RetinopathyDRNCT06272565
Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetic Retinopathy, Diabetic Macular Edema, Anti-vascular Endothelial Growth Factor
- Type of treatment
- Injection or infusion
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. CON (non diabetes control group)：Non diabetes patients undergoing phacoemulsification surgery. 2. NDR (non diabetes retinopathy diabetes patients): Non DR diabetes patients undergoing phacoemulsification surgery. 3. NPDR (non proliferative diabetes retinopathy): DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery. 4. PDR (proliferative diabetes retinopathy): DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery.
Who may be able to join
- Patients > 40 years old.
- CON (non diabetes control group)：patients undergoing phacoemulsification surgery.
- NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.
- NPDR (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months.
- PDR (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months.
- Patients voluntarily signed informed consent.
Who cannot join
- CON (non diabetes control group)：patients with a history of other ophthalmic operations.
- NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.
- NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.
- PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。
- Patients with active ocular inflammation, high myopia, pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Ophthalmic Center of Sun Yat-sen University
Guangzhou, Guangdong, 510623
Zhongshan Ophthalmic Center of Sun Yat-sen University, 86+13560323773, chh5413@126.com
About this study
Official title: An Approach of Exploring the Mechanism of the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage Based on Metabolomics Methods
Diabetic retinopathy (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.
- Keywords
- Diabetic retinopathy, metabolomics, NLPR3, Diabetic Macular edema, Anti-vascular endothelial growth factor
- 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 |
|---|---|---|
| CON(Non diabetes control group) | Non diabetes patients undergoing phacoemulsification surgery | |
| NDR(Non diabetes retinopathy diabetes patients) | Non DR diabetes patients undergoing phacoemulsification surgery | |
| NPDR (non proliferative diabetes retinopathy) | DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery | |
| PDR (proliferative diabetes retinopathy) | DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Untargeted metabolomics for metabolic profile using UHPLC/MS
Aqueous humor samples in DR patients will be analysed to putatively identify metabolic profile by comparison with control samples using ultra-high performance liquid chromatography-high resolution mass spectrometer (UHPLC/MS). UHPLC/MS analysis allows the simultaneous high-resolution measurement of a broad range of metabolites, hence the untargeted nature of the analysis.
For the UHPLC/MS results, perform normalization, standardization, and log transformation, then compare the metabolite differences between groups.
Multivariate statistical analysis and Partial least squares discriminant analysis included in the mass spectrometry software will be used to analyse UHPLC/MS results to identify metabolites that best discriminate between DR and control conditions. The evaluation of significant metabolite results is based on: P-value and Fold change.
Measured: 24 weeks
Secondary outcomes (2)
Best-corrected visual acuity
Best-corrected visual acuity at baseline and 24 weeks follow-up
Measured: 24 weeks
Central subfield thickness
Central subfield thickness at baseline and 24 weeks follow-up
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start3 Jul 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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 Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272565
- Sponsor's protocol ID
- 2023KYPJ292
- Acronym
- DR
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Approach of Exploring the Mechanism of the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage Based on Metabolomics Methods
- ClinicalTrials.gov ID
- NCT06272565
- Acronym / sponsor ID
- DR / 2023KYPJ292
- Keywords
- Diabetic retinopathy, metabolomics, NLPR3, Diabetic Macular edema, Anti-vascular endothelial growth factor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 3 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Feb 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 (DR) is one of the most serious microvascular complications of diabetes. Early diagnosis and treatment of diabetes is the key to prevent visual impairment in DR patients. This study aims to use a non-targeted metabolomics detection technique combined with ultra-high performance liquid chromatography time-of-flight mass spectrometry to analyze the metabolomics profile in aqueous humor sample of DR patents, and further explore the mechanism of the relationship between differential metabolites and their metabolic pathways with NLRP3 activation in DR inflammatory damage. DR patients with macular edema will receive anti-vascular endothelial growth factor (anti-VEGF) treatment; these patients will be divided into two groups: responders group and non-responders group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CON(Non diabetes control group) | – | –Non diabetes patients undergoing phacoemulsification surgery |
| NDR(Non diabetes retinopathy diabetes patients) | – | –Non DR diabetes patients undergoing phacoemulsification surgery |
| NPDR (non proliferative diabetes retinopathy) | – | –DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery |
| PDR (proliferative diabetes retinopathy) | – | –DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. CON (non diabetes control group)：Non diabetes patients undergoing phacoemulsification surgery. 2. NDR (non diabetes retinopathy diabetes patients): Non DR diabetes patients undergoing phacoemulsification surgery. 3. NPDR (non proliferative diabetes retinopathy): DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery. 4. PDR (proliferative diabetes retinopathy): DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery.
Key inclusion criteria (6 listed)
- Patients > 40 years old.
- CON (non diabetes control group)：patients undergoing phacoemulsification surgery.
- NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.
- NPDR (non proliferative diabetes retinopathy): patients with history of diabetes, fundus microangiopathy shown by fundus fluorescein angiography, including microangioma, hard exudation, wadding exudation and other non proliferative diabetes retinopathy signs, and did not receive invasive ophthalmic treatment within 3 months.
- PDR (proliferative diabetes retinopathy): patients with a history of diabetes, fundus neovascular lesions shown by fundus fluorescein angiography, and did not receive invasive ophthalmic treatment within 3 months.
Key exclusion criteria (5 listed)
- CON (non diabetes control group)：patients with a history of other ophthalmic operations.
- NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.
- NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.
- PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。
- Patients with active ocular inflammation, high myopia, pregnancy.
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
Untargeted metabolomics for metabolic profile using UHPLC/MS
Time frame: 24 weeks
Aqueous humor samples in DR patients will be analysed to putatively identify metabolic profile by comparison with control samples using ultra-high performance liquid chromatography-high resolution mass spectrometer (UHPLC/MS). UHPLC/MS analysis allows the simultaneous high-resolution measurement of a broad range of metabolites, hence the untargeted nature of the analysis. For the UHPLC/MS results, perform normalization, standardization, and log transformation, then compare the metabolite differences between groups. Multivariate statistical analysis and Partial least squares discriminant analysis included in the mass spectrometry software will be used to analyse UHPLC/MS results to identify metabolites that best discriminate between DR and control conditions. The evaluation of significant metabolite results is based on: P-value and Fold change.
2 secondary outcomes
Best-corrected visual acuity
Time frame: 24 weeks
Central subfield thickness
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy and Diabetic Macular Edema, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Chen, PHD (0086-20-87330000, chh5413@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Untargeted metabolomics for metabolic profile using UHPLC/MS (time frame: 24 weeks). 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 1 Jul 2024.