Trial Condition(s):

Ophthalmology, Macular Edema, Macular degeneration

Evaluation of changes in visual acuity in patients with diabetic macular edema (DME) starting treatment with an approved anti-VEGF therapy (POLARIS)

Bayer Identifier:

16459

ClinicalTrials.gov Identifier:

NCT01771081

EudraCT Number:

Not Available

Study Completed

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.

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 Summary

Enrollment Goal
911
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Portugal

Status
Completed
 
Locations

Investigative Site

Many Locations, Greece

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, Slovakia

Status
Completed
 
Locations

Investigative Site

Many Locations, United Kingdom

Status
Completed
 

Trial Design