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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Bevacizumab; Endothelial Growth Factors; Ranibizumab

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