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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01771081
First received: January 11, 2013
Last updated: August 5, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in retinal thickness, measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, after 12 month ] [ Designated as safety issue: No ]
  • Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group [ Time Frame: Baseline, after each month, up to 12 month ] [ Designated as safety issue: No ]
  • Resource utilization in terms of treatment choices, frequency and duration [ Time Frame: Baseline, after 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 807
Study Start Date: April 2013
Estimated Study Completion Date: April 2015
Estimated 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

Genders Eligible for Study:   Both
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

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

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Withdrawn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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01771081     History of Changes
Other Study ID Numbers: 16459, NN1201
Study First Received: January 11, 2013
Last Updated: August 5, 2014
Health Authority: France: National Board of Physicians (C.N.O.M "Comité National de l'Ordre des Médecins)
Germany: Ethics Committee
UK: UK Research Ethics Committee, UK National Health Service, Research and Development Department at each site
Italy: Ethics Committee, Italian Authority for Privacy and data Protection (Garante per la Privacy)
Portugal:Ethics Committee
Russia: Ethics Committee
Spain: Ethics Committee
Slovac Republic: Ethics Committee
Greece: Ethics Committee

Keywords provided by Bayer:
Longitudinal Studies,
Observation
Epidemiology

Additional relevant MeSH terms:
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014