Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- systemic inflammatory biomarkes correlates with OCT biomarkers and higher in poor responders
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
switched from bevacizumab to ranibizumab 0.5
Intervention: serum samples (Diagnostic Test)
Group 1
switched from bevacizumab to ranibizumab 0.5
Intervention: dexamethasone implant versus ranibizumab (Drug)
Group 2
switched from bevacizumab to dexamethasone implant
Intervention: serum samples (Diagnostic Test)
Group 2
switched from bevacizumab to dexamethasone implant
Intervention: dexamethasone implant versus ranibizumab (Drug)
Outcomes
Primary Outcomes
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
- The anatomical and visual recovery will be compared to dexamethasone versus ranibizumab(6 months)
Investigators
Büşra Çoban
Ophthalmology Resident
Saglik Bilimleri Universitesi