About this trial

Despite the evidence that diabetic retinopathy (DR) remains the first cause of blindness among the working-age population, it lacks a specific preventive treatment. This is because early mechanisms leading to the development of DR have been, until recently, unknown. Recent studies have suggested that the early stages of DR could be preceded by neuronal abnormalities, in particular retinal ganglion cell death, coupled with widespread retinal inflammation. According to these studies, endothelial dysfunction and the development of microaneurysms, the classic hallmarks of DR, could be the consequence of these early abnormalities.

This project will aim to verify whether neurodegeneration could represent at the same time: 1) a risk factor for subsequent development of DR (this will be investigated through a follow-up study in type 2 diabetic patients free of diabetic retinopathy). 2) a biomarker of the complication (if so, patients with long-standing diabetes in the absence of retinopathy should show no signs of neurodegeneration).

Eligibility criteria

Qualifiers

Participant is willing and able to give informed consent for participation in the trial.

Male or Female, aged 40 - 80 years;

In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications;

HbA1c level 7% or greater;

Disqualifiers

retinal or systemic diseases other than diabetes;

hypertension (BP values greater than 140/90 mm Hg);

anemia (hematocrit less than 35%);

smoking;

Trial design

Treatments tested in this trial

  • Ophthalmological examination including imaging assessments
  • confocal analysis of cornea
  • Dynamic Vessel Analyzer (DVA)
  • tear sampling collection
  • blood sampling collection

Treatment groups

180 Participants
are divided into 4 treatment groups

Locations

2
IRCCS Ospedale San Raffaele _O.U. Ophthalmology20123, MilanItaly, Italy
Irccs Ospedale San Raffaele20132, MilanItaly/milan, Italy

Sponsors and collaborators

IRCCS Ospedale San Raffaele

Lead sponsor