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

Medical University of Vienna

Status: Terminated

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00704652

394/2007

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 2 patient groups

A

Description:

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

B

Description:

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.