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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | switched from bevacizumab to ranibizumab 0.5 |
| |
| Group 2 | switched from bevacizumab to dexamethasone implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| serum samples | Diagnostic Test | The serum samples were taken from the patients at the 3rd month (switch point) |
|
| 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 |
| 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. 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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treatment naive patients who were diagnosed with diabetic macular edema and had poor response to the 3 consecutive bevacizumab intravitreal injection loading phase.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Dr. Cemil Tascioglu City Hospital | Istanbul | Sisli | 34384 | Turkey (Türkiye) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2026 | |
| Reset | Feb 23, 2026 | |
| Release | Feb 27, 2026 | |
| Reset | Mar 19, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2026 | Feb 23, 2026 | |||
| Feb 27, 2026 |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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blood samples (serum)
| dexamethasone implant versus ranibizumab | Drug | dexamethasone implant versus ranibizumab will be studied as a secondary outcome |
|
| Mar 19, 2026 |