Patient recruitment was not sufficient to achieve the needed patient numbers.
EPOinDR
Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus
Sponsor study identifier
observational
5
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2009
Actual (reported)Study Completion
September 2009
Actual (reported)The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 23, 2008
Actual (reported)June 25, 2008
Actual (reported)September 2009
Actual (reported)September 2009
Actual (reported)Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients
9 month
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
Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation)
Diabetic patients with renal insufficiency and in need of recombinant human EPO (darbepoetin alfa) substitution because of inadequate erythropoiesis. In both groups the target haemoglobin level is 10-12 gHb/ml, all treatment is performed according to label.
Diabetic patients with min. Grade 2 renal insufficiency, and in Group B with anemia that is to be treated with systemic ESA therapy.
Departmen of Ophthalmology, Medical Unversity of Vienna
Vienna, State of Vienna, 1090, Austria
Ursula Schmidt-Erfurth, Prof.
Departmen of Ophthalmology, Medical Unversity of Vienna
5 participants (actual enrollment reported by the registry).
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Sirolimus to Treat Diabetic Macular Edema
Contact the study team to confirm eligibility.
Primary Completion
September 2009
Actual (reported)Study Completion
September 2009
Actual (reported)Last Updated
April 7, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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