Diabetic Macular Edema, Inflammation
Conditions
Keywords
diabetic macular edema, biomarkers, inflammation, optical coherence tomography
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.
Interventions
DIAGNOSTIC_TESTserum samples
The serum samples were taken from the patients at the 3rd month (switch point)
DRUGdexamethasone implant versus ranibizumab
dexamethasone implant versus ranibizumab will be studied as a secondary outcome
Sponsors
Saglik Bilimleri Universitesi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed