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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

911 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ophthalmology Macular Edema Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Groups

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Group1

Ranibizumab (or other DME treatment)

Intervention Type DRUG

Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment

Interventions

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Ranibizumab (or other DME treatment)

Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No