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

Recruiting

• Conditions: Diabetes Complications

• Registration Number: NCT05944640
• Lead Sponsor: Charles University, Czech Republic

Brief Summary

Our project investigates the new characteristics of diabetic retinopathy using liquid eye biopsy in combination with novel parameters of glucose control obtained with continuous glucose monitoring. This approach will bring new knowledge and implications for future therapies.

Detailed Description

Diabetic retinopathy is one of the most common causes of blindness in developed countries. The short-term glucose fluctuations have been suggested as a factor contributing to the risk of diabetic complications including ocular complications. We hypothesize that modulatory and other biological abilities of miRNAs and inflammatory chemokines/cytokines have a significant impact on the development and the progression of diabetic retinopathy. Our main goal is to identify the biomarkers that will in time be used for new screening, diagnostic, and treatment strategies for patients with diabetic retinopathy, bring a better prevention and early treatment to them and thus improve their quality of life while saving the cost associated with advanced forms of retinopathy.

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2023-02-07
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
miRNA	Year 2025	miRNA expression measuer by real-time PCR method in plasma and vitreous samples (units: threshold cycle)
TIR	Year 2025	Percentage of time in target ranges

Secondary Outcome Measures

Name	Time	Method
Glycemic variability	Year 2025	Expressed as the standard deviation
Mean sensor glucose concentration	Year 2025	Measured by rtCGM
miRNA expression differences	Year 2025	miRNA expression differences analysis between diabetic patients with and without diabetic retinopathy (units: fold change)

Trial Locations

Locations (1)

General University Hospital in Prague; 🇨🇿 Prague, Czechia