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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01771081
First received: January 11, 2013
Last updated: October 27, 2015
Last verified: October 2015
  Purpose
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 Intervention
Ophthalmology
Macular Edema
Macular Degeneration
Drug: Ranibizumab (or other DME treatment)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 911
Study Start Date: April 2013
Study Completion Date: April 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771081

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01771081     History of Changes
Other Study ID Numbers: 16459
NN1201 ( Other Identifier: Company internal )
Study First Received: January 11, 2013
Last Updated: October 27, 2015

Keywords provided by Bayer:
Longitudinal Studies,
Observation
Epidemiology

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

ClinicalTrials.gov processed this record on April 21, 2017