Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Medical University of Vienna Amgen
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00704652

Purpose

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
Diabetic Retinopathy

MedlinePlus related topics: Diabetes Diabetic Eye Problems Retinal Disorders

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients [ Time Frame: 9 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients. [ Time Frame: 9 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
A Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation)
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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Diabetic patients with min. Grade 2 renal insufficiency, and in Group B with anemia that is to be treated with systemic ESA therapy.

Criteria

Inclusion Criteria:

Group A:

Males and females aged 18 to 80 yrs
Diabetes mellitus type 1 or 2
Haemoglobin level above the treatment threshold level (as described in the drug description)
Receiving no darbepoetin alfa treatment
Best Corrected Visual Acuity (BCVA) better than 20/200
No clinically significant macular edema (CSME) or CSME already treated with laser photocoagulation.

Group B:

Males and females aged 18 to 80 yrs
Diabetes mellitus type 1 or2
Anaemia (due to renal failure), haemoglobin level under the treatment threshold level before the initialisation of the therapy (as described in the drug label)
Starting to receive darbepoetin alfa treatment (darbepoetin alfa, Aranesp, Amgen)
BCVA better than 20/200
No clinically significant macular edema (CSME) or CSME already treated with laser photocoagulation.

Exclusion Criteria:

History of retinal disease other than DR
History of intraocular surgery, including laser treatment in the past 4 month
A major change in the insulin treatment of the patient in the past 4 month or during the follow up period.
Inability to communicate in German or English
Dementia; inability to follow commands
Epilepsy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704652

Contacts

Contact: Gábor Deák, Dr.

+43-1-40400-7969

gabor-gyoergy.deak@meduniwien.ac.at

Locations

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

Sponsors and Collaborators

Medical University of Vienna

Amgen

Investigators

Principal Investigator:

Ursula Schmidt-Erfurth, Prof.

Departmen of Ophthalmology, Medical Unversity of Vienna

More Information

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

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009