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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179030
• Other study ID #: E-48670771
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: October 17, 2023

Study information

• Verified date: December 2023
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 17, 2023
• Est. primary completion date: October 17, 2023
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Inflammation
• Macular Edema

Intervention

Diagnostic Test:
• serum samples
The serum samples were taken from the patients at the 3rd month (switch point)

Drug:
• dexamethasone implant versus ranibizumab
dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Locations

Country	Name	City	State
Turkey	Prof. Dr. Cemil Tascioglu City Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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