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

Completed

• Conditions: Inflammation; Diabetic Macular Edema
• Interventions: Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab

• Registration Number: NCT06179030
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief 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.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-10-17
• Study Completion: 2023-10-17
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-18
• Study First Posted: 2023-12-21
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2024-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	dexamethasone implant versus ranibizumab	switched from bevacizumab to ranibizumab 0.5
Group 1	serum samples	switched from bevacizumab to ranibizumab 0.5
Group 2	dexamethasone implant versus ranibizumab	switched from bevacizumab to dexamethasone implant
Group 2	serum samples	switched from bevacizumab to dexamethasone implant

Primary Outcome Measures

Name	Time	Method
systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders	6 months	serum inflammatory biomarkers such as ICAM-1, MCP-1 , Il-6, IL-8, VEGF-A and TNFa will be studied. then, the levels of the aferometioned parameters will be compared with the treatment response and OCT parameters.

Secondary Outcome Measures

Name	Time	Method
The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab	6 months	The groups will be compared regarding to anatomical and visual improvement. The anatomical improvement wil be assessed by central macular thickness measured by spectral domain OCT. The best corrected visual acuity change will be assessed by snellen and LogMAR.

Trial Locations

Locations (1)

Prof. Dr. Cemil Tascioglu City Hospital; 🇹🇷 Istanbul, Sisli, Turkey