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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Anti-vascular Endothelial Growth Factor; Diabetic Macular Edema; Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT06272565

2023KYPJ292

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 4 patient groups

CON(Non diabetes control group)

Description:

Non diabetes patients undergoing phacoemulsification surgery

NDR(Non diabetes retinopathy diabetes patients)

Description:

Non DR diabetes patients undergoing phacoemulsification surgery

NPDR (non proliferative diabetes retinopathy)

Description:

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

PDR (proliferative diabetes retinopathy)

Description:

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