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

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

Official Title
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Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus

Conditions
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Diabetic Retinopathy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation) | |
| B<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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