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

Bayer

Status: Completed

Conditions: Macular Degeneration; Ophthalmology; Macular Edema

Treatments: Drug: Ranibizumab (or other DME treatment)

Study type: Observational

Funder types: Industry

Identifiers

NCT01771081

16459

NN1201 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 911 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

911 participants in 1 patient group

Group1

Treatment:

Drug: Ranibizumab (or other DME treatment)