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

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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)

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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