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

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.

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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

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI

Coimbra, Coimbra District, 3000-548, Portugal

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

CSME needing Photocoagulation

Time frame: 24 months

Secondary outcomes

Vision Loss

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Collaborators

Fundação para a Ciência e a Tecnologia

Registry information

Acronym: CPM

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2011
First posted: Oct 1, 2008
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.

Published trials that share one or more normalized conditions with this study.

Completed