Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus (EPOinDR)

This study has been terminated.

(Patient recruitment was not sufficient to achieve the needed patient numbers.)

Sponsor:

Collaborator:

Amgen

Information provided by:

Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00704652

First received: June 23, 2008

Last updated: September 17, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 23, 2008

Last Updated Date

September 17, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00704652 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus

Official Title ^ICMJE

Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus

Brief Summary

The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Diabetic Retinopathy

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00704652

Other Study ID Numbers ^ICMJE

394/2007

Has Data Monitoring Committee

Responsible Party

Prof. Ursula Schmidt-Erfurth, Department of Ophthalmology, Medical University Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Amgen

Investigators ^ICMJE

Principal Investigator:

Ursula Schmidt-Erfurth, Prof.

Departmen of Ophthalmology, Medical Unversity of Vienna

Information Provided By

Medical University of Vienna

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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