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

NCT ID: NCT00704652

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2009-09-30

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.

Conditions

Diabetic Retinopathy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation)

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gabor Deak

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ursula Schmidt-Erfurth, Prof.

Role: PRINCIPAL_INVESTIGATOR

Departmen of Ophthalmology, Medical Unversity of Vienna

Locations

Departmen of Ophthalmology, Medical Unversity of Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

394/2007

Identifier Type: -

Identifier Source: org_study_id