Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures

To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers:

• Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and
• Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.

Inclusion criteria

• Diabetes type 2 according to 1985 WHO criteria
• Age between 35 and 75 years
• Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
• Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
• Best Corrected Visual Acuity >= 75 letters (>= 20 /32)
• Refraction with a spherical equivalent less than 5 Dp
• Informed consent

Exclusion criteria

• Cataract or other eye disease that may interfere with fundus examinations
• Glaucoma
• Any eye surgery within a period of 6-months
• Other retinal vascular disease
• Previous laser therapy
• Dilatation of the pupil < 5 mm