Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage

NCT ID: NCT06272565

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-03

Study Completion Date

2026-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy Diabetic Macular Edema Anti-vascular Endothelial Growth Factor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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CON(Non diabetes control group)

Non diabetes patients undergoing phacoemulsification surgery

No interventions assigned to this group

NDR(Non diabetes retinopathy diabetes patients)

Non DR diabetes patients undergoing phacoemulsification surgery

No interventions assigned to this group

NPDR (non proliferative diabetes retinopathy)

DR patients with no sign of any neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery

No interventions assigned to this group

PDR (proliferative diabetes retinopathy)

DR patients with neovascularization suggested by fluorescein sodium angiography and receiving intravitreal injection surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients \> 40 years old.
2. CON (non diabetes control group):patients undergoing phacoemulsification surgery.
3. NDR (non diabetes retinopathy diabetes patients): patients with diabetes history and undergoing phacoemulsification surgery.
4. 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.
5. 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.
6. Patients voluntarily signed informed consent.

Exclusion Criteria

1. CON (non diabetes control group):patients with a history of other ophthalmic operations.
2. NDR (non diabetes retinopathy diabetes patients): patients with fundus changes of diabetes retinopathy or other ophthalmic surgery history.
3. NPDR (non proliferative diabetes retinopathy): patients with fundus neovascular lesions shown by fundus fluorescein angiography.
4. PDR (proliferative diabetes retinopathy):patients undergoing vitrectomy。
5. Patients with active ocular inflammation, high myopia, pregnancy.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Ophthalmic Center of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Hui Chen, PHD

Role: CONTACT

0086-20-87330000

Facility Contacts

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Zhongshan Ophthalmic Center of Sun Yat-sen University

Role: primary

86+13560323773

Other Identifiers

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2023KYPJ292

Identifier Type: -

Identifier Source: org_study_id

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