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

Saglik Bilimleri Universitesi

Status: Completed

Conditions: Inflammation; Diabetic Macular Edema

Treatments: Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab

Study type: Observational

Funder types: Other

Identifiers

NCT06179030

E-48670771

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• who had refractory DME after 3 consecutive initial bevacizumab therapy
• treatment-naive

Exclusion criteria

• who had underwent anti-vegf treatment previously
• systemic inflammatory disease
• who had ocular surgery 6 months prior to enrollment
• uncontrolled hypertension
• <18 years old

Trial design

80 participants in 2 patient groups

Group 1

Description:

switched from bevacizumab to ranibizumab 0.5

Treatment:

Diagnostic Test: serum samples

Drug: dexamethasone implant versus ranibizumab

Group 2

Description:

switched from bevacizumab to dexamethasone implant

Treatment:

Diagnostic Test: serum samples

Drug: dexamethasone implant versus ranibizumab