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

Diabetic Retinopathy Clinical Trial

— CPM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763802
• Other study ID #: PTDC/SAU-OSM/72635/2006
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: April 4, 2014
• Start date: September 2007
• Est. completion date: May 2011

Study information

• Verified date: April 2014
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: AIBILI-Comissão de Ética para a Saúde
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Macular Edema
• Retinal Diseases

Locations

Country	Name	City	State
Portugal	AIBILI	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	Fundação para a Ciência e a Tecnologia

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Cunha-Vaz J, Bernardes R. Nonproliferative retinopathy in diabetes type 2. Initial stages and characterization of phenotypes. Prog Retin Eye Res. 2005 May;24(3):355-77. Epub 2004 Dec 16. Review. — View Citation

Hayreh SS. Diabetic papillopathy and nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2002 Nov-Dec;47(6):600-2; author reply 602. — View Citation

Lobo CL, Bernardes RC, Figueira JP, de Abreu JR, Cunha-Vaz JG. Three-year follow-up study of blood-retinal barrier and retinal thickness alterations in patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy. Arch Ophthalmol. 2004 Feb;122(2):211-7. — View Citation

Pires I, Bernardes RC, Lobo CL, Soares MA, Cunha-Vaz JG. Retinal thickness in eyes with mild nonproliferative retinopathy in patients with type 2 diabetes mellitus: comparison of measurements obtained by retinal thickness analysis and optical coherence tomography. Arch Ophthalmol. 2002 Oct;120(10):1301-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSME needing Photocoagulation		24 months	Yes
Secondary	Vision Loss		24 months	No

External Links

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