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Search / Trial NCT05944640

Dynamic Parameters of Glucose Control in Relation to Biomarkers in Serum and Intraocular Fluid in Patients With Diabetes

Launched by CHARLES UNIVERSITY, CZECH REPUBLIC · Jul 6, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Biomarkers Retinopathy Mi Rna Diabetes Mellitus Glucose Variability

ClinConnect Summary

This clinical trial is studying how certain features of glucose control relate to eye health in patients with diabetes, particularly those experiencing diabetic retinopathy, which is damage to the eyes caused by diabetes. Researchers will use a new method called liquid eye biopsy along with continuous glucose monitoring to gather important information. The goal is to learn more about these conditions and help develop better treatments in the future.

To participate in the study, individuals must be at least 18 years old and have either type 1 or type 2 diabetes, with a history of using insulin for at least five years. They should also have any form of diabetic retinopathy or macular edema and have a specific blood sugar level (HbA1c) below 10%. Participants will need to provide written consent before starting. It's important to note that those with certain eye conditions or recent treatments may not be eligible. Overall, this study aims to shed light on how managing blood sugar can impact eye health in people with diabetes.

Gender

ALL

Eligibility 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

About Charles University, Czech Republic

Charles University, located in the Czech Republic, is a prestigious institution renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive academic expertise and state-of-the-art facilities to conduct innovative research that aims to improve patient outcomes and contribute to the global medical community. With a focus on ethical standards and rigorous scientific methodologies, Charles University collaborates with various stakeholders to explore new therapies and enhance healthcare practices, fostering a culture of excellence in clinical research.

Locations

Prague, , Czechia

Patients applied

0 patients applied

Trial Officials

Martin Prázný, Prof.

Principal Investigator

Charles University and General University Hospital in Prague

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported