Skip to main content
OpenTrials
Completed

NCT Number: NCT06179030

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, Sisli, 34384, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum samples

Diagnostic Test

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

dexamethasone implant versus ranibizumab

Drug

dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Primary outcomes

  1. systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2023
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.