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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetic Macular Edema, Inflammation

Intervention / Treatment
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* Diagnostic Test: serum samples
* Drug: dexamethasone implant versus ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>switched from bevacizumab to ranibizumab 0.5 | Diagnostic Test: serum samples<br>* The serum samples were taken from the patients at the 3rd month (switch point)<br>Drug: dexamethasone implant versus ranibizumab<br>* dexamethasone implant versus ranibizumab will be studied as a secondary outcome<br>|
| Group 2<br>switched from bevacizumab to dexamethasone implant | Diagnostic Test: serum samples<br>* The serum samples were taken from the patients at the 3rd month (switch point)<br>Drug: dexamethasone implant versus ranibizumab<br>* dexamethasone implant versus ranibizumab will be studied as a secondary outcome<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders | 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab | The groups will be compared regarding to anatomical and visual improvement. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic macular edema, biomarkers, inflammation, optical coherence tomography