Clinical trial NCT00704652: Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus
Official title: Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetic Retinopathy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-06-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients with min. Grade 2 renal insufficiency, and in Group B with anemia that is to be treated with systemic ESA therapy.

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 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

Primary outcomes:
measure: Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients
timeFrame: 9 month
Secondary outcomes:
measure: Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients.
timeFrame: 9 month
measure: Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients.
timeFrame: 9 month
measure: Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients.
timeFrame: 9 month
measure: Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients.
timeFrame: 9 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Departmen of Ophthalmology, Medical Unversity of Vienna
Study officials:
affiliation: Departmen of Ophthalmology, Medical Unversity of Vienna
name: Ursula Schmidt-Erfurth, Prof.
role: PRINCIPAL_INVESTIGATOR
References: