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

Charles University, Czech Republic

Status: Enrolling

Conditions: Diabetes Complications

Treatments: Procedure: Intraocular surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05944640

NU22-01-00077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

213 participants in 3 patient groups

Patients with DR

Description:

Adult patients with T1DM or T2DM with any form of diabetic retinopathy and diabetic macular edema, indicated for ocular surgical procedure as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery.

Treatment:

Procedure: Intraocular surgery

Patients without DR

Description:

Adult patients with T1DM or T2DM without any signs of diabetic retinopathy, indicated for ocular surgical procedure from other reasons as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery.

Treatment:

Procedure: Intraocular surgery

Control group

Description:

Subjects without diabetes mellitus indicated for ocular surgery from other reasons (cataract, retinal detachment, macular hole, idiopathic epiretinal membrane) as standard of care. Blood samples and samples of intraocular fluids will bee taken during the ocular surgery.

Treatment:

Procedure: Intraocular surgery