Status:
TERMINATED
Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Amgen
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-80 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00704652
Start Date
May 1 2008
End Date
September 1 2009
Last Update
April 7 2015
Active Locations (1)
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1
Departmen of Ophthalmology, Medical Unversity of Vienna
Vienna, Vienna, Austria, 1090