Type 2 Diabetes Clinical Trial
Official title:
Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures
The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).
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.
;
Observational Model: Cohort, Time Perspective: Prospective
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