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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
  • Study Primary Completion Date: January 2015

Interventions

  • 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

Arms, Groups and Cohorts

  • Group1

Clinical Trial Outcome Measures

Primary Measures

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

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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