Diabetic RetinopathyEPOinDRNCT00704652
Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus
An observational study of Diabetic Retinopathy, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 5 participants
- Where
- 1 siteAustria
- Study dates
- May 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Departmen of Ophthalmology, Medical Unversity of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus
The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients
Measured: 9 month
Secondary outcomes (4)
Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients.
Measured: 9 month
Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients.
Measured: 9 month
Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients.
Measured: 9 month
Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Patient recruitment was not sufficient to achieve the needed patient numbers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Gabor Deak, Medical University of Vienna
- Investigators
- Ursula Schmidt-Erfurth, Prof., Principal investigator, Departmen of Ophthalmology, Medical Unversity of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704652
- Sponsor's protocol ID
- 394/2007
- Acronym
- EPOinDR
- Status last verified
- Apr 2015
- First submitted
- 23 Jun 2008
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional and Morphological Retinal Changes in the Course of Systemic Aranesp Treatment in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00704652
- Acronym / sponsor ID
- EPOinDR / 394/2007
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient recruitment was not sufficient to achieve the needed patient numbers.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- May 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients
Time frame: 9 month
4 secondary outcomes
Functional improvement in best corrected visual acuity (BCVA) and microperimetry following darbepoetin alpha therapy compared to control patients.
Time frame: 9 month
Changes in anterior chamber flare and cell count following darbepoetin alpha therapy compared to control patients.
Time frame: 9 month
Changes in the fundus image and fluorescein angiographic features following darbepoetin alpha therapy compared to control patients.
Time frame: 9 month
Changes in blood count, chemistry, Astrup and blood clotting following darbepoetin alpha therapy compared to control patients.
Time frame: 9 month
Results and safety
The study was stopped early (reason given: Patient recruitment was not sufficient to achieve the needed patient numbers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Schmidt-Erfurth, Prof. principal investigator
Departmen of Ophthalmology, Medical Unversity of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient recruitment was not sufficient to achieve the needed patient numbers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphologic changes in the retina detected by HD-OCT following darbepoetin alpha therapy compared to control patients (time frame: 9 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.