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NCT07602348Active, not recruiting

Assessment of Retinal-Angio Findings In Patients With Diabetes Type II Treated With Novel Antidiabetic Therapies

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

ARIADNE is a prospective observational cohort study of patients with type 2 diabetes mellitus (T2DM) treated with daily metformin and scheduled to initiate treatment with newer antidiabetic agents, such as sodium-glucose cotransporter 2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1RAs). These newer antidiabetic agents have demonstrated significant benefits in improving glycaemic control; however, some studies suggest that their rapid glucose-lowering effects may be associated with transient worsening or progression of retinal complications. The purpose of this study is to evaluate the efficacy and safety of newer antidiabetic agents on retinal vasculature and visual acuity, and to investigate how these changes are associated with alterations in markers of peripheral endothelial and cardiovascular function.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
40 (actual)
First submitted
24 Apr 2026
Start date
1 Mar 2024
Primary completion date
30 Jan 2026
Lead sponsor
University of Athens
NCT number
NCT07602348

What you commit to

  • Study type: Observational
  • Participants enrolled: 40
  • From 1 Mar 2024 to the primary completion date, 30 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have received intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy or corticosteroids within the last 6 months.
  • Patients who have undergone cataract surgery or vitrectomy within the last 6 months.

Other illness

  • History of multiple severe hypoglycaemic episodes during the past two years.
  • History of ketoacidosis or metabolic acidosis.
  • Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.

Other

  • Patients who are pregnant or breastfeeding.
  • Patients who have undergone panretinal photocoagulation within the last 6 months.

Who the study is looking for

  • Individuals aged ≥18 years.
  • Male and/or female patients with T2DM diagnosed according to the criteria established by the EASD and the ADA.
  • Patients receiving only metformin as antidiabetic treatment.
  • Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.
  • Patients who are able to provide informed consent for participation in the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
2nd Department of Ophthalmology, Attikon University Hospital, National and Kapodistrian University of Athens
Coordinator of this site? Confirm its status
AthensGreeceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.