Skip to main content
OpenTrials
Completed

NCT Number: NCT01771081

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ophthalmology Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ranibizumab (or other DME treatment)

Drug

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 outcomes

  1. Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN

    Time frame: Baseline, after 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: POLARIS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
Oct 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.