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

European Vision Institute Clinical Research Network374 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

374

Conditions

Type 2 Diabetes Non Proliferative Diabetic Retinopathy

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diabetes type 2 according to 1985 WHO criteria 2. Age between 35 and 75 years 3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography 4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2 5. Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32) 6. Refraction with a spherical equivalent less than 5 Dp 7. Informed consent Exclusion Criteria: 1. Cataract or other eye disease that may interfere with fundus examinations 2. Glaucoma 3. Any eye surgery within a period of 6-months 4. Other retinal vascular disease 5. Previous laser therapy 6. Dilatation of the pupil \< 5 mm

Locations (1)

Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, Coimbra District, Portugal

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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