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

Study Overview
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Brief Summary
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The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

Detailed Description
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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.

Official Title
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Identifying Progression of Retinal Disease in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures

Conditions
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Type 2 Diabetes, Non Proliferative Diabetic Retinopathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type-2 diabetes, NPDR<br>Type-2 diabetic patients with NPDR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify progressors | To identify progressors in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify correlations between progressors and study outcomes. | To identify correlations between progressors and the different study outcomes. To explore the parameters, and to identify highly predictive outcomes. | 12 months |