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:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00763802
First received: September 30, 2008
Last updated: April 4, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Vision Loss [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: September 30, 2008
Last Updated: April 4, 2014
Health Authority: Portugal: AIBILI-Comissão de Ética para a Saúde

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

ClinicalTrials.gov processed this record on October 16, 2014