Identifying progression of retinal disease in eyes with NPDR in diabetes type 2 using non-invasive procedures.

Completed

Conditions: non-proliferative diabetic retinopathy
10012653
diabetes related eye disorder
10047061

Registration Number: NL-OMON36161

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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 field color fundus photography, Presence of at least 1 microaneurysm in the central 3000 micrometer area (corresponding to 2 DA) Field 2, Best corrected visual acuity better than or equal to 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To identify progressors in retinal vascular disease and central retinal edema<br /><br>in type 2 diabetic patients with early NPDR, based on retinal disease<br /><br>progression from baseline to the 12-month visit, the following biomarkers will<br /><br>be assessed:<br /><br>* Microaneurysms turnover (MA formation rate more than 2, i.e. number of new MA<br /><br>from baseline to the 12-month visit) computed from color fundus photographs<br /><br>using the RetmarkerDR software; and<br /><br>* Retinal thickness increase in eyes with retinal thickening (Increase in<br /><br>retinal thickness above normal range) in the central subfield, the inner ring<br /><br>and/or the outer ring Constantly Present, Present or Absent (as measured by OCT<br /><br>and considering the macula thickness normative data, annex 18.4).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To identify correlations between progressors and study outcomes in order to<br /><br>characterize eyes/patients that show worsening and are candidates for<br /><br>relatively short term trials of early NPDR. The following study outcomes will<br /><br>be assessed:<br /><br>* MA turnover (MA formation and disappearance rates);<br /><br>* retinal thickness changes in the central subfield; the inner ring and/or the<br /><br>outer ring;<br /><br>* BCVA changes;<br /><br>* ETDRS step changes; and<br /><br>* rescue treatment (laser)</p><br>