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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Diabetic Macular Edema
• Intervention / Treatment: Diagnostic test: serum samples; Drug: dexamethasone implant versus ranibizumab

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • Istanbul, Sisli, Turkey, 34384
      • Prof. Dr. Cemil Tascioglu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; switched from bevacizumab to ranibizumab 0.5	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
Group 2; switched from bevacizumab to dexamethasone implant	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): October 17, 2023
• Study Completion (Actual): October 17, 2023

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; diabetic macular edema; optical coherence tomography; inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Inflammation; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Dexamethasone; Ranibizumab
• Other Study ID Numbers: E-48670771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No