NCT00704652

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

June 23, 2008

Last Update Submit

April 6, 2015

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients

    9 month

Secondary Outcomes (4)

  • 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

Study Arms (2)

A

Diabetic patients suffering from renal insufficiency with stable haemoglobin levels (receiving no EPO supplementation)

B

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmen of Ophthalmology, Medical Unversity of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Ursula Schmidt-Erfurth, Prof.

    Departmen of Ophthalmology, Medical Unversity of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 23, 2008

First Posted

June 25, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

AU(1)