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

NCT06179030 | Completed FDA Drug FDA Device

• 1 other identifier: E-48670771
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema; Inflammation

Keywords

diabetic macular edema; biomarkers; inflammation; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab

  6 months

Study Arms (2)

Group 1

switched from bevacizumab to ranibizumab 0.5

Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab

Group 2

switched from bevacizumab to dexamethasone implant

Diagnostic Test: serum samples; Drug: dexamethasone implant versus ranibizumab

Interventions

serum samples DIAGNOSTIC_TEST

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

Group 1; Group 2

dexamethasone implant versus ranibizumab DRUG

dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

treatment naive patients who were diagnosed with diabetic macular edema and had poor response to the 3 consecutive bevacizumab intravitreal injection loading phase.

You may qualify if:

• who had refractory DME after 3 consecutive initial bevacizumab therapy
• treatment-naive

You may not qualify if:

• who had underwent anti-vegf treatment previously
• systemic inflammatory disease
• who had ocular surgery 6 months prior to enrollment
• uncontrolled hypertension
• \<18 years old

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, 34384, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples (serum)

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmology Resident

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 21, 2023
• Study Start: May 1, 2022
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

TU (1)