OphthalmologyPOLARISNCT01771081
Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy
An observational study of Ophthalmology and Macular Edema, run by Bayer at 8 sites in 8 countries.
Trial summary
POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ophthalmology, Macular Edema, Macular Degeneration
- What is being tested?
- Ranibizumab (or other DME treatment)
- How many people
- 911 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Apr 2013to Apr 2015
- 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: In- and outpatients at participating sites with a diagnosis of DME with central involvement. Patients will be enrolled after the decision for treatment with an approved anti-VEGF therapy has been made at or after October 2012 by the study physician.
Who may be able to join
- Patients diagnosed with type 1 or 2 diabetes mellitus
- Patients diagnosed with DME with central involvement (defined as the area of the center subfield of optical coherence tomography [OCT])
- Patients for whom the decision has been made to treat with an approved anti-VEGF therapy prior to inclusion into the study
- Patients who received the first approved intravitreal anti VEGF treatment from October 01, 2012
- Patients who give informed consent in writing for study participation
Who cannot join
- Treatment with any anti-VEGF therapy prior to the start of the observation period (October 01, 2012) or enrolment into the study
- Participation in an investigational program with interventions out of clinical routine practice
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
About this study
Official title: POLARIS: A Non-interventional Study in Patients With Diabetic Macular Edema (DME) With Central Involvement to Assess the Effectiveness of Existing Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment Regimens
POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.
- Conditions
- Ophthalmology, Macular Edema, Macular Degeneration
- Being tested
- Ranibizumab (or other DME treatment)
- Keywords
- Longitudinal Studies,, Observation, Epidemiology
- Medical subject headings
- Macular Edema, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab (or other DME treatment)Drug
Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Not described Receives: Drug: Ranibizumab (or other DME treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
Measured: Baseline, after 12 months
Secondary outcomes (6)
Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)
Measured: Baseline
Mean time from diagnosis to first commencement with an approved anti-VEGF therapy
Measured: Date of first diagnosis; Date of treatment initiation: up to 24 month
Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)
Measured: Baseline, after 12 month
Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group
Measured: Baseline, after each month, up to 12 month
Resource utilization in terms of treatment choices, frequency and duration
Measured: Baseline, after 6 and 12 months
Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice
Measured: Baseline, after 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OphthalmologyStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Cohort
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771081
- Sponsor's protocol ID
- 16459
- Other IDs
- NN1201
- Acronym
- POLARIS
- Status last verified
- Oct 2015
- First submitted
- 11 Jan 2013
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLARIS: A Non-interventional Study in Patients With Diabetic Macular Edema (DME) With Central Involvement to Assess the Effectiveness of Existing Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment Regimens
- ClinicalTrials.gov ID
- NCT01771081
- Acronym / sponsor ID
- POLARIS / 16459
- Conditions
- Ophthalmology, Macular Edema, Macular Degeneration
- Keywords
- Longitudinal Studies,, Observation, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Jan 2013 (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.
POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Drug: Ranibizumab (or other DME treatment) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In- and outpatients at participating sites with a diagnosis of DME with central involvement. Patients will be enrolled after the decision for treatment with an approved anti-VEGF therapy has been made at or after October 2012 by the study physician.
Key inclusion criteria (5 listed)
- Patients diagnosed with type 1 or 2 diabetes mellitus
- Patients diagnosed with DME with central involvement (defined as the area of the center subfield of optical coherence tomography [OCT])
- Patients for whom the decision has been made to treat with an approved anti-VEGF therapy prior to inclusion into the study
- Patients who received the first approved intravitreal anti VEGF treatment from October 01, 2012
- Patients who give informed consent in writing for study participation
Key exclusion criteria (2 listed)
- Treatment with any anti-VEGF therapy prior to the start of the observation period (October 01, 2012) or enrolment into the study
- Participation in an investigational program with interventions out of clinical routine practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ranibizumab (or other DME treatment)Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment | Drug | Group1 |
Primary outcome
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
Time frame: Baseline, after 12 months
6 secondary outcomes
Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)
Time frame: Baseline
Mean time from diagnosis to first commencement with an approved anti-VEGF therapy
Time frame: Date of first diagnosis; Date of treatment initiation: up to 24 month
Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)
Time frame: Baseline, after 12 month
Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group
Time frame: Baseline, after each month, up to 12 month
Resource utilization in terms of treatment choices, frequency and duration
Time frame: Baseline, after 6 and 12 months
Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice
Time frame: Baseline, after 6 and 12 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 28 Oct 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.
Bayer Study Director study director
Bayer
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmology and Macular Edema, run by Bayer at 8 sites in 8 countries.
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 5 inclusion and 2 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 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Germany, Greece, Portugal, Russia and 3 more countries. 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?
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN (time frame: Baseline, after 12 months). 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 28 Oct 2015.