Exploring the Interaction Between Metabolic Disorders and NLPR3 Inflammasome Activation in DR Inflammatory Damage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy, Diabetic Macular Edema, Anti-vascular Endothelial Growth Factor. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Primary outcome measures
- Untargeted metabolomics for metabolic profile using UHPLC/MS [Time frame: 24 weeks]
Secondary outcome measures (2)
- Best-corrected visual acuity [Time frame: 24 weeks]
- Central subfield thickness [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Zhongshan Ophthalmic Center of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT06272565 · 2023KYPJ292