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Completed

NCT Number: NCT00840541

Phenotyping Diabetic Retinopathy

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).

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI - Clinical Trial Center

Coimbra, Coimbra District, 3000-548, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. CSME

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Feb 10, 2009
Registry last updated
Apr 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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