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

April 6, 2015 updated by: Gabor Deak, Medical University of Vienna

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Departmen of Ophthalmology, Medical Unversity of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients
Time Frame: 9 month
9 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients.
Time Frame: 9 month
9 month
Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients.
Time Frame: 9 month
9 month
Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients.
Time Frame: 9 month
9 month
Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients.
Time Frame: 9 month
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Amgen

Investigators

  • Principal Investigator: Ursula Schmidt-Erfurth, Prof., Departmen of Ophthalmology, Medical Unversity of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 394/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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