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Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2 (CPM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763802
First Posted: October 1, 2008
Last Update Posted: April 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
  Purpose
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.

Condition
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

Resource links provided by NLM:


Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • CSME needing Photocoagulation [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Vision Loss [ Time Frame: 24 months ]

Enrollment: 400
Study Start Date: September 2007
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
MNPDR
Type 2 diabetic patients with Mild non-prolipherative retinopathy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetic patients with Mild non-prolipherative retinopathy fulfilling the inclusion criterion.
Criteria

Inclusion Criteria:

  • Diabetes type 2 according to 1985 WHO criteria.
  • Age between 35 and 75 years.
  • Mild non-prolipherative retinopathy (based on ETDRS criteria)
  • Best Corrected Visual acuity >20 /25
  • Refraction with a spherical equivalent less than 5 Dp.
  • Inform consent

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Glaucoma
  • Vitreous syneresis or posterior vitreous detachment
  • Other retinal vascular disease
  • Recent intraocular surgery
  • Previous laser therapy
  • Dilatation of the pupil < 5 mm
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763802


Locations
Portugal
AIBILI
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Fundação para a Ciência e a Tecnologia
Investigators
Principal Investigator: José G Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00763802     History of Changes
Other Study ID Numbers: PTDC/SAU-OSM/72635/2006
First Submitted: September 30, 2008
First Posted: October 1, 2008
Last Update Posted: April 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Diabetic Angiopathies
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus, Type 2
Macular Degeneration
Retinal Degeneration
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases