Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy (POLARIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01771081
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : October 28, 2015
Regeneron Pharmaceuticals
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment
Ophthalmology Macular Edema Macular Degeneration Drug: Ranibizumab (or other DME treatment)

Study Type : Observational
Actual Enrollment : 911 participants
Observational Model: Cohort
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
Study Start Date : April 2013
Primary Completion Date : January 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group1 Drug: 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

Primary Outcome Measures :
  1. Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN [ Time Frame: Baseline, after 12 months ]

Secondary Outcome Measures :
  1. Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME) [ Time Frame: Baseline ]
  2. 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 ]
  3. Changes in retinal thickness, measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, after 12 month ]
  4. Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group [ Time Frame: Baseline, after each month, up to 12 month ]
  5. Resource utilization in terms of treatment choices, frequency and duration [ Time Frame: Baseline, after 6 and 12 months ]
  6. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01771081

Many Locations, France
Many Locations, Germany
Many Locations, Greece
Many Locations, Portugal
Russian Federation
Many Locations, Russian Federation
Many Locations, Slovakia
Many Locations, Spain
United Kingdom
Many Locations, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01771081     History of Changes
Other Study ID Numbers: 16459
NN1201 ( Other Identifier: Company internal )
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Bayer:
Longitudinal Studies,

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents