Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus
Terminated
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT00704652
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients 9 month
- Secondary Outcome Measures
Name Time Method 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 blood count, chemistry, Astrup and blood clotting 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
Trial Locations
- Locations (1)
Departmen of Ophthalmology, Medical Unversity of Vienna
🇦🇹Vienna, Austria