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

June 23, 2008
September 17, 2009
May 2008
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00704652 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus
Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
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.

Diabetic Retinopathy
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00704652
394/2007
No
Prof. Ursula Schmidt-Erfurth, Department of Ophthalmology, Medical University Vienna
Medical University of Vienna
Amgen
Principal Investigator: Ursula Schmidt-Erfurth, Prof. Departmen of Ophthalmology, Medical Unversity of Vienna
Medical University of Vienna
September 2009

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