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Sponsors and Collaborators: |
Medical University of Vienna Amgen |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00704652 |
The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.
Condition |
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Diabetic Retinopathy |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus |
Estimated Enrollment: | 40 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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A
Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation)
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B
Diabetic patients with renal insufficiency and in need of recombinant human EPO (darbepoetin alfa) substitution because of inadequate erythropoiesis. In both groups the target haemoglobin level is 10-12 gHb/ml, all treatment is performed according to label.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Diabetic patients with min. Grade 2 renal insufficiency, and in Group B with anemia that is to be treated with systemic ESA therapy.
Inclusion Criteria:
Group A:
Group B:
Exclusion Criteria:
Contact: Gábor Deák, Dr. | +43-1-40400-7969 | gabor-gyoergy.deak@meduniwien.ac.at |
Austria | |
Departmen of Ophthalmology, Medical Unversity of Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Gábor Deák, Dr. +43-1-40400-7969 gabor-gyoergy.deak@meduniwien.ac.at |
Principal Investigator: | Ursula Schmidt-Erfurth, Prof. | Departmen of Ophthalmology, Medical Unversity of Vienna |
Responsible Party: | Department of Ophthalmology, Medical University Vienna ( Prof. Ursula Schmidt-Erfurth ) |
Study ID Numbers: | 394/2007 |
Study First Received: | June 23, 2008 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00704652 |
Health Authority: | Austria: Ethikkommission |
Metabolic Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Darbepoetin alfa Endocrine System Diseases Diabetic Angiopathies |
Diabetic Retinopathy Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Retinal Diseases Diabetes Complications |
Cardiovascular Diseases |