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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-10-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Macular Edema Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

switched from bevacizumab to ranibizumab 0.5

serum samples

Intervention Type DIAGNOSTIC_TEST

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

dexamethasone implant versus ranibizumab

Intervention Type DRUG

dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Group 2

switched from bevacizumab to dexamethasone implant

serum samples

Intervention Type DIAGNOSTIC_TEST

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

dexamethasone implant versus ranibizumab

Intervention Type DRUG

dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Interventions

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serum samples

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

Intervention Type DIAGNOSTIC_TEST

dexamethasone implant versus ranibizumab

dexamethasone implant versus ranibizumab will be studied as a secondary outcome

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No