Phenotyping Diabetic Retinopathy

April 4, 2014 updated by: Association for Innovation and Biomedical Research on Light and Image

Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes

The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Study Overview

Status

Completed

Conditions

Detailed Description

This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.

Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

Study Type

Observational

Enrollment (Actual)

80

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, 3000-548
        • AIBILI - Clinical Trial Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.

Description

Inclusion Criteria:

  • Diagnosis of DR.
  • Females or Males;
  • Age over 18 years;
  • Signed Informed Consent;
  • Previous follow-up with regular systemic and ophthalmic assessments.

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations;
  • Vitreous syneresis or posterior vitreous detachment;
  • 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
DR
Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CSME
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Investigators

  • Principal Investigator: José Cunha-Vaz, MD PhD, Association for Innovation and Biomedical Research on Light and Image

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

Helpful Links

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

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2014

Last Update Submitted That Met QC Criteria

April 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTM018A

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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