check_circleStudy Completed

Ophthalmology, Macular Edema, Macular Degeneration

Bayer Identifier:

16459

ClinicalTrials.gov Identifier:

NCT01771081

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of changes in visual acuity in patients with diabetic macular edema (DME) starting treatment with an approved anti-VEGF therapy

Trial 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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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


  • - 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 summary

Enrollment Goal
911
Trial Dates
April 2013 - April 2015
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany
Completed
Many Locations, France
Withdrawn
Many Locations, Italy
Completed
Many Locations, Spain
Completed
Many Locations, Portugal
Completed
Many Locations, Greece
Completed
Many Locations, Russia
Completed
Many Locations, Slovakia
Completed
Many Locations, United Kingdom

Primary Outcome

  • Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
    date_rangeTime Frame:
    Baseline, after 12 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from diagnosis to first commencement with an approved anti-VEGF therapy
    date_rangeTime Frame:
    Date of first diagnosis; Date of treatment initiation: up to 24 month
    enhanced_encryption
    Safety Issue:
    No
  • Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)
    date_rangeTime Frame:
    Baseline, after 12 month
    enhanced_encryption
    Safety Issue:
    No
  • Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group
    date_rangeTime Frame:
    Baseline, after each month, up to 12 month
    enhanced_encryption
    Safety Issue:
    No
  • Resource utilization in terms of treatment choices, frequency and duration
    date_rangeTime Frame:
    Baseline, after 6 and 12 months
    enhanced_encryption
    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
    date_rangeTime Frame:
    Baseline, after 6 and 12 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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