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

Diabetic Retinopathy Clinical Trial

— EPOinDR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00704652
• Other study ID #: 394/2007
• Status: Terminated
• Phase: N/A
• First received: June 23, 2008
• Last updated: April 6, 2015
• Start date: May 2008
• Est. completion date: September 2009

Study information

• Verified date: April 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy

Locations

Country	Name	City	State
Austria	Departmen of Ophthalmology, Medical Unversity of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Amgen

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients		9 month	No
Secondary	Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients.		9 month	No
Secondary	Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients.		9 month	No
Secondary	Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients.		9 month	No
Secondary	Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients.		9 month	No