NCT06179030

Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Saglik Bilimleri Universitesi · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: —

Summary

The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes.

Detailed description

This study was designed as a prospective open-label non rondomised observational study. The study was registered between April 18, 2022 and October 18, 2023. It is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive DME in the Retina Department of Prof Dr Cemil Tascioglu City Hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. It was planned to evaluate systemic and local(OCT biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. The markers planned to be checked in blood samples are: IL-6, IL-8, TNF-a, ICAM-1, MCP-1, VEGF, HbA1c, CRP, ESR, haemogram, creatinine, AST, ALT, cholesterol. Patients were followed up monthly for 3 months after the switching. It was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. In addition, local OCT biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.

Conditions

• Diabetic Macular Edema
• Inflammation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	serum samples	The serum samples were taken from the patients at the 3rd month (switch point)
DRUG	dexamethasone implant versus ranibizumab	dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-10-17
• Completion: 2023-10-17
• First posted: 2023-12-21
• Last updated: 2024-01-02

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study
• FDA-regulated device study