Investigating glucose control and biomarkers in diabetic retinopathy
Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Diabetic Patients With Ocular Complications
Charles University, Czech Republic · NCT05944640
This study is testing if monitoring glucose levels and eye fluid can help find new ways to prevent and treat diabetic retinopathy for people with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 213 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT05944640 on ClinicalTrials.gov |
What this trial studies
This project explores the characteristics of diabetic retinopathy by utilizing liquid eye biopsy alongside continuous glucose monitoring to assess glucose variability. The study aims to identify biomarkers related to miRNAs and inflammatory chemokines that may influence the development and progression of diabetic retinopathy. By understanding these relationships, the research seeks to inform new screening, diagnostic, and treatment strategies for patients, ultimately improving prevention and early intervention efforts. The findings could lead to enhanced quality of life for patients and reduced healthcare costs associated with advanced retinopathy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes who have been on insulin for at least five years and have any form of diabetic retinopathy.
Not a fit: Patients with active intraocular inflammation, uncontrolled glaucoma, or recent intravitreal therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and treatment strategies for diabetic retinopathy, enhancing patient outcomes.
How similar studies have performed: While the approach of combining liquid biopsy with glucose monitoring is innovative, similar studies have shown promise in understanding diabetic complications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * type 1 or type 2 diabetes * ≥ 18 years old * treatment with insulin for at least 5 years prior baseline * any form of diabetic retinopathy and macular edema * HbA1c \< 10% * written informed consent prior to starting study related activity Exclusion Criteria: * any active intraocular or periocular infectious or non-infectious inflammation in study eye * uncontrolled glaucoma * history of intraocular inflammation or trauma in study eye * intravitreal anti-VEGF therapy in study eye during a 3-month perido prior to baseline * use of corticosteroid intravitreal implant in study eye at any time
Where this trial is running
Prague
- General University Hospital in Prague — Prague, Czechia (RECRUITING)
Study contacts
- Principal investigator: Martin Prázný, Prof. — Charles University and General University Hospital in Prague
- Study coordinator: Martin Prázný, Prof.
- Email: mpra@lf1.cuni.cz
- Phone: +420737122570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Complications, biomarkers, retinopathy, miRNA, diabetes mellitus, glucose variability