RetinopathyNCT00828425
Management of Diabetes Mellitus Patients With Retinopathy
An observational study of Retinopathy and Diabetes Mellitus, run by AstraZeneca at 62 sites in Switzerland.
Trial summary
Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed: which medication are used to keep blood pressure under control? which medication are used for metabolic control? the average control… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinopathy, Diabetes Mellitus
- How many people
- 2,500 participants
- Where
- 62 sitesSwitzerland
- Study dates
- Dec 2008to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetic patients with diabetic retinopathy
Who may be able to join
- Diabetic patients
- Diabetic retinopathy
Who cannot join
None listed.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
Switzerland62 sites
Research Site
Aigle, Canton of Vaud
Research Site
Alle, Canton of Jura
Research Site
Ardon, Valais
Research Site
Ascona, Canton Ticino
Research Site
Basel, Canton of Basel-City
Research Site
Bassersdorf, Canton of Zurich
Research Site
Bassins, Canton of Vaud
Research Site
Bern, Canton of Bern
Research Site
Bex, Canton of Vaud
Research Site
Chateau-d'Oex, Canton of Vaud
Research Site
Chur, Kanton Graubünden
Research Site
Clarens, Canton of Vaud
Research Site
Collonge-Bellerive, Canton of Geneva
Research Site
Dättwil, Canton of Aargau
Research Site
Diegten, Basel-Landschaft
Research Site
Egg, Canton of Zurich
Research Site
Estavayer-le-Lac, Canton of Fribourg
Research Site
Evionnaz, Valais
Research Site
Eysins, Canton of Vaud
Research Site
Fribourg, Canton of Fribourg
Research Site
Geneva, Canton of Geneva
Research Site
Hausen B. Brugg, Canton of Aargau
Research Site
Ilanz, Kanton Graubünden
Research Site
Kerns, Canton of Obwalden
Research Site
Kreuzlingen, Thurgau
Research Site
Küssnacht, Canton of Schwyz
Research Site
Laufen, Basel-Landschaft
Research Site
Lausanne, Canton of Vaud
Research Site
Le Grand-Saconnex, Canton of Geneva
Research Site
Le Locle, Canton of Neuchâtel
Research Site
Lenzburg, Canton of Aargau
Research Site
Les Acacias, Canton of Geneva
Research Site
Locarno, Canton Ticino
Research Site
Lucerne, Canton of Lucerne
Research Site
Lugano, Canton Ticino
Research Site
Lupfig, Canton of Aargau
Research Site
Moutier, Canton of Bern
Research Site
Muri, Canton of Aargau
Research Site
Nyon, Canton of Vaud
Research Site
Oberuzwil, Canton of St. Gallen
Research Site
Prilly, Canton of Vaud
Research Site
Renens VD, Canton of Vaud
Research Site
Rheinfelden, Canton of Aargau
Research Site
Rorschach, Canton of St. Gallen
Research Site
Rothenburg, Canton of Lucerne
Research Site
Salavaux, Canton of Vaud
Research Site
Samedan, Kanton Graubünden
Research Site
Sankt Gallen, Canton of St. Gallen
Research Site
Savièse, Valais
Research Site
Schaffhausen, Canton of Schaffhausen
Research Site
Schinznach Dorf, Canton of Aargau
Research Site
Sierre, Valais
Research Site
Sion, Valais
Research Site
Spreitenbach, Canton of Aargau
Research Site
St-Legier, Canton of Vaud
Research Site
Tuggen, Canton of Schwyz
Research Site
Unterseen, Canton of Bern
Research Site
Versoix, Canton of Geneva
Research Site
Vevey, Canton of Vaud
Research Site
Viganello, Canton Ticino
Research Site
Wangs, Canton of St. Gallen
Research Site
Winterthur, Canton of Zurich
About this study
Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed:
- which medication are used to keep blood pressure under control?
- which medication are used for metabolic control?
- the average control level of metabolism and blood pressure is compliant with the international guidelines?
- laser photocoagulation plays a role in the control of metabolism and blood pressure?
- there are differences in the control of metabolism and blood pressure between patients with DM I or DM II?
- there is an influence of renal failure on the choose of medication?
- Conditions
- Retinopathy, Diabetes Mellitus
- Keywords
- Diabetes Mellitus, retinopathy, Management of diabetic patients with retinopathy
- Medical subject headings
- Retinal Diseases, Diabetes Mellitus
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 |
|---|---|---|
| 1 | Diabetic patients with retinopathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight
Measured: every 3 months
evolution of diabetic retinopathy
Measured: every 3 months
Secondary outcomes (1)
concomitant medication
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startDec 2008
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinopathyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828425
- Sponsor's protocol ID
- NIS-CCH-DUM-2008/1
- Status last verified
- Aug 2010
- First submitted
- 23 Jan 2009
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Diabetes Mellitus Patients With Retinopathy
- ClinicalTrials.gov ID
- NCT00828425
- Acronym / sponsor ID
- NIS-CCH-DUM-2008/1
- Conditions
- Retinopathy, Diabetes Mellitus
- Keywords
- Diabetes Mellitus, retinopathy, Management of diabetic patients with retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Study completion
- Aug 2009 (actual)
- First posted
- 26 Jan 2009 (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.
Aim of this NIS is to retrospectively document the management of diabetic patients with retinopathy in a naturalistic setting in Switzerland. Following elements are going to be analyzed:
- which medication are used to keep blood pressure under control?
- which medication are used for metabolic control?
- the average control level of metabolism and blood pressure is compliant with the international guidelines?
- laser photocoagulation plays a role in the control of metabolism and blood pressure?
- there are differences in the control of metabolism and blood pressure between patients with DM I or DM II?
- there is an influence of renal failure on the choose of medication?
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Diabetic patients with retinopathy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetic patients with diabetic retinopathy
Key inclusion criteria (2 listed)
- Diabetic patients
- Diabetic retinopathy
Key exclusion criteria (0 listed)
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
Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight
Time frame: every 3 months
evolution of diabetic retinopathy
Time frame: every 3 months
1 secondary outcome
concomitant medication
Time frame: every 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinopathy and Diabetes Mellitus, run by AstraZeneca at 62 sites in Switzerland.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood lipids, glycemia, HbA1C, blood creatinine, proteinuria, body weight (time frame: every 3 months). The study lists 2 primary outcomes in all. 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 18 Aug 2010.