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Recruiting Not applicable NCT07536516

Measurement of Ocular Blood Flow and Retinal Oxygen Extraction in Diabetic Patients

No applicable phase (e.g. observational)
Conditions: Diabetes Mellitus

Sponsor: Medical University of Vienna

trial.available_in: БГ
Overview
The prevalence of diabetes is increasing, with type 2 diabetes mellitus comprising over 90% of cases. Diabetes mellitus complications, including diabetic retinopathy (DR), impose significant health burdens. GLP-1 receptor agonists (GLP-1RAs) and dual GIP/GLP-1 receptor agonists show promise in improving cardiovascular and kidney outcomes, but their effects on retinal microvasculature and neuroprotection remain unclear. This study investigates the impact of GLP-1RAs (semaglutide, liraglutide) and GIP/GLP-1-dual agonists (tirzepatide) on ocular blood flow and retinal function in DM patients.
Who can participate
Inclusion Criteria: * Men and women aged ≥ 18 years * Signed informed consent * Previously diagnosed diabetes mellitus * Normal ophthalmic findings except diabetic retinopathy, unless the investigator considers an abnormality to be clinically irrelevant * Planned initiation of therapy with GLP-1 receptor agonist (Semaglutide, Ozempic®; Liraglutide, Victoza®) or GIP/GLP-1 receptor agonist (Tirzepatide, Mounjaro®) by a diabetes specialist Exclusion Criteria: * Participation in a clinical trial in the 3 weeks preceding the screening visit * Symptoms of a clinically relevant illness in the 3 weeks before the first study day * Presence or history of a severe medical condition, except diabetes, as judged by the clinical investigator * Abuse of alcoholic beverages * Blood donation during the previous three weeks * Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator * Previous laser photocoagulation treatment in the study eye * Best corrected visual acuity \< 0.4 Snellen * Women of childbearing potential (neither menopausal, nor hysterectomized, nor sterilized) not using effective contraception * Pregnancy, planned pregnancy or lactation
Interventions
• Laser Speckle Flowgraphy (LSFG)
DEVICE
• Optical Coherence Tomography (OCT)
DEVICE
• Optical Coherence Tomography Angiography (OCT-A)
DEVICE
Locations 1
Austria (1)
Medical University Vienna
Vienna , State of Vienna
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.11.2025
Completion date
01.06.2026
Registry ID
NCT07536516
Source
clinicaltrials.gov
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