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

European Vision Institute Clinical Research Network

Status: Completed

Conditions: Type 2 Diabetes; Non Proliferative Diabetic Retinopathy

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01145599

ECR-RET-2010-02

Details and patient eligibility

About

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

Full description

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.

Enrollment: 374 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

374 participants in 1 patient group

Type-2 diabetes, NPDR

Description:

Type-2 diabetic patients with NPDR.