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

Completed

• Conditions: Type 2 Diabetes; Non Proliferative Diabetic Retinopathy

• Registration Number: NCT01145599
• Lead Sponsor: European Vision Institute Clinical Research Network

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-16
• Study Start: 2010-09
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify "progressors"	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Identify correlations between "progressors" and study outcomes.	12 months	To identify correlations between "progressors" and the different study outcomes.; To explore the parameters, and to identify highly predictive outcomes.

Trial Locations

Locations (1)

Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image; 🇵🇹 Coimbra, Portugal