HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 30, 2006

Last Updated Date

January 23, 2008

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00600236 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population

Official Title ^†

HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population

Brief Summary

One of the first causes of irreversible blindness in mexican population is diabetic retinopathy which is clearly diferent between patients the time of evolution and development of retinopathy and complications. The aim of this study is to explore the inmunogenetic profile and the influence of HLA in this variations of the sickness to predict the severity of diabetic complications.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Non-Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Diabetes Mellitus Type 2
Proliferative Diabetic Retinopathy

Intervention ^†

Procedure: blood sample

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Estimated Enrollment ^†

300

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Diabetes mellitus type 2 with 10 years of diagnosis and no diabetic retinopathy
Diabetes mellitus type 2 with 10 years of diagnosis and proliferative retinopathy

Exclusion Criteria:

Systemic hipertension
Cardic disease
Lupus
Any kind of artritis
Allergies
Optic Neuritis
VKH
Cancer
Inmunological diseases

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Mexico

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00600236

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Asociación para Evitar la Ceguera en México

Collaborators ^††

Instituto Nacional de Referencia Epidemiológica (INdRE)

Investigators ^†

Principal Investigator:

Hugo Quiroz-Mercado, MD

Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"

Information Provided By

Asociación para Evitar la Ceguera en México

Verification Date

January 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.