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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145599
• Other study ID #: ECR-RET-2010-02
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: February 10, 2015
• Start date: September 2010

Study information

• Verified date: November 2013
• Source: European Vision Institute Clinical Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: Europe: European Medicines Agency and European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). According to the study type (observational/interventional) the study will be submitted to each national Competent Authorities.Portugal: Ethics Committee for Clinical Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Non Proliferative Diabetic Retinopathy
• Retinal Diseases
• Type 2 Diabetes

Locations

Country	Name	City	State
Portugal	Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image	Coimbra

Sponsors (1)

Lead Sponsor	Collaborator
European Vision Institute Clinical Research Network

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No