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
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus

Resource links provided by NLM:


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 ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Departmen of Ophthalmology, Medical Unversity of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Amgen
Investigators
Principal Investigator: Ursula Schmidt-Erfurth, Prof. Departmen of Ophthalmology, Medical Unversity of Vienna
  More Information

No publications provided

Responsible Party: Prof. Ursula Schmidt-Erfurth, Department of Ophthalmology, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00704652     History of Changes
Other Study ID Numbers: 394/2007
Study First Received: June 23, 2008
Last Updated: September 17, 2009
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Retinopathy
Retinal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014