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Management of Diabetes Mellitus Patients With Retinopathy

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00828425
First received: January 23, 2009
Last updated: August 17, 2010
Last verified: August 2010
History of Changes
  Purpose

Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed:

  • which medication are used to keep blood pressure under control?
  • which medication are used for metabolic control?
  • the average control level of metabolism and blood pressure is compliant with the international guidelines?
  • laser photocoagulation plays a role in the control of metabolism and blood pressure?
  • there are differences in the control of metabolism and blood pressure between patients with DM I or DM II?
  • there is an influence of renal failure on the choose of medication?

Condition
Retinopathy
Diabetes Mellitus

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Management of Diabetes Mellitus Patients With Retinopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • evolution of diabetic retinopathy [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • concomitant medication [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: December 2008
Study Completion Date: August 2009
Groups/Cohorts
1
Diabetic patients with retinopathy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetic patients with diabetic retinopathy

Criteria

Inclusion Criteria:

  • Diabetic patients
  • Diabetic retinopathy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828425

  Show 62 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: Dr. Med. Dirk Schneider - Medical Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00828425     History of Changes
Other Study ID Numbers: NIS-CCH-DUM-2008/1
Study First Received: January 23, 2009
Last Updated: August 17, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by AstraZeneca:
Diabetes Mellitus
retinopathy
Management of diabetic patients with retinopathy

Additional relevant MeSH terms:
Diabetes Mellitus
Retinal Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013