Completed

POLARISAssessment of Anti-VEGF Treatment Effectiveness in Diabetic Macular Edema with Central Involvement

What is being collected

Data Collection

Who is being recruted

Eye Diseases+2

+ Macular Degeneration

+ Macular Edema

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: April 2013

See protocol details

Summary

Principal SponsorBayer

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

The study focuses on individuals who have Diabetic Macular Edema (DME) with central involvement, a condition that affects the eye's retina due to diabetes. The main goal is to evaluate the effectiveness of existing treatments that target a specific protein called vascular endothelial growth factor (VEGF). These treatments, known as anti-VEGF regimens, are currently used to manage DME. The importance of this study lies in understanding how well these treatments work in real-world settings, potentially improving care and addressing challenges faced by patients with this condition.

Official TitlePOLARIS: 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

NCT01771081

Principal SponsorBayer

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

911 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesMacular DegenerationMacular EdemaRetinal DegenerationRetinal Diseases

Criteria

5 inclusion criteria required to participate

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

Show More Criteria

2 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers