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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00704652

Acronym

EPOinDR

Enrollment

Registered

2008-06-25

Start date

2008-05-31

Completion date

2009-09-30

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Austria

Outcome results