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

February 10, 2015 updated by: European Vision Institute Clinical Research Network

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

374

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3030-548
        • Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type-2 diabetes, NPDR

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify "progressors"
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify correlations between "progressors" and study outcomes.
Time Frame: 12 months

To identify correlations between "progressors" and the different study outcomes.

To explore the parameters, and to identify highly predictive outcomes.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Vision Institute Clinical Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

June 15, 2010

First Posted (Estimate)

June 16, 2010

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECR-RET-2010-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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